Chrysalis Intelligence · Sponsors · Aesculap, Inc.

Aesculap, Inc.

Center Valley, PA, US · 13 510(k) clearances · 20 recalls

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Total clearances
13
2020-03-17 → 2025-05-13
Last 12 months
0
Product codes
8
Most recent
2025-05-13
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Class II General Hospital 4 2025-05-13
JXG Shunt, Central Nervous System And Components Class II Neurology 2 2024-12-16
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 2 2020-12-18
HAE Rongeur, Manual Class II Neurology 1 2023-06-29
HCI — — — 1 2021-12-13
HBE — — — 1 2021-08-24
IZI — — — 1 2021-01-21
FZP Clip, Implantable Class II General, Plastic Surgery 1 2020-09-02
Safety

Recalls (20)

Class I (serious)
0
Risk of injury / death
Total recalls
20
Currently ongoing
20
Most recent
2026-01-15
DateSeverityStatusRecall # ProductCodeReason
2026-01-15 Class II Ongoing Z-1485-2026 Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Vers… — There is the potential for the length of the trocar shaft to be too long.
2025-09-24 Class II Ongoing Z-0312-2026 Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N… — It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
2025-09-24 Class II Ongoing Z-0311-2026 Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/… — It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
2025-09-24 Class II Ongoing Z-0310-2026 Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A… — It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
2025-09-24 Class II Ongoing Z-0309-2026 Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Ver… — It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
2025-08-18 Class II Ongoing Z-0027-2026 AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R. — Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
2025-08-18 Class II Ongoing Z-0026-2026 AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. — Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
2025-01-31 Class II Ongoing Z-1312-2025 Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R… — The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
2025-01-31 Class II Ongoing Z-1311-2025 Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover… — The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
2025-01-31 Class II Ongoing Z-1310-2025 Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM; (2) REF BH304R, … — The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
2025-01-31 Class II Ongoing Z-1309-2025 Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartmann… — The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
2025-01-31 Class II Ongoing Z-1308-2025 Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ… — The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
2024-05-13 Class II Ongoing Z-2139-2024 Aeos Robotic Digital Microscope, Product Code: PV010 — Possibility of the robotic arm to drop more than 10cm from its original position after pressing the emergency stop button due to failure of the integrated safet…
2024-01-09 Class II Ongoing Z-1247-2024 DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures. — The sterile blister packaging may be damaged, and sterility may be compromised.
2024-01-09 Class II Ongoing Z-1246-2024 DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures. — The sterile blister packaging may be damaged, and sterility may be compromised.
2024-01-09 Class II Ongoing Z-1245-2024 DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures. — The sterile blister packaging may be damaged, and sterility may be compromised.
2024-01-09 Class II Ongoing Z-1244-2024 DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures. — The sterile blister packaging may be damaged, and sterility may be compromised.
2024-01-09 Class II Ongoing Z-1243-2024 DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures. — The sterile blister packaging may be damaged, and sterility may be compromised.
2023-12-29 Class II Ongoing Z-0867-2024 MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM" — Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue…
2023-12-29 Class II Ongoing Z-0866-2024 MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM"; — Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue…
Filings

All 510(k) clearances (13)

Date K-number Device Code Class Specialty
2025-05-13 K242762 Aesculap Aicon® Series Container System KCT Class II General Hospital
2024-12-16 K242003 XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set JXG Class II Neurology
2023-06-29 K223596 SQ.line KERRISON HAE Class II Neurology
2022-12-30 K214041 Aesculap AICON Container KCT Class II General Hospital
2021-12-13 K211572 Aesculap Slim Clip Applier HCI — —
2021-08-24 K203739 ELAN 4 Electro Motor System HBE — —
2021-01-21 K202391 DIR 800 IZI — —
2020-12-18 K203461 Aesculap Caiman 12 Seal and Cut Technology System GEI Class II General, Plastic Surgery
2020-10-30 K202938 Aesculap Caiman 5 Seal and Cut Technology System GEI Class II General, Plastic Surgery
2020-09-02 K202124 Aesculap PAS-Port Proximal Anastomosis System FZP Class II General, Plastic Surgery
2020-05-08 K200950 Ventricular Catheter JXG Class II Neurology
2020-03-27 K192056 JJ Series Container System KCT Class II General Hospital
2020-03-17 K193582 SterilContainer S2 System KCT Class II General Hospital
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence