Chrysalis Intelligence · Sponsors · Ethicon Endo Surgery, LLC

Ethicon Endo Surgery, LLC

Guaynabo, PR · 1 510(k) clearances · 4 recalls

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Total clearances
1
2023-08-29 → 2023-08-29
Last 12 months
0
Product codes
1
Most recent
2023-08-29
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FZP Clip, Implantable Class II General, Plastic Surgery 1 2023-08-29
Safety

Recalls (4)

Class I (serious)
0
Risk of injury / death
Total recalls
4
Currently ongoing
4
Most recent
2025-03-07
DateSeverityStatusRecall # ProductCodeReason
2025-03-07 Class II Ongoing Z-1516-2025 ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH — Identified curing issues with the silicone during the needles manufacturing process.
2025-03-07 Class II Ongoing Z-1515-2025 PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM — Identified curing issues with the silicone during the needles manufacturing process.
2025-03-07 Class II Ongoing Z-1514-2025 PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1 — Identified curing issues with the silicone during the needles manufacturing process.
2025-03-07 Class II Ongoing Z-1513-2025 PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP — Identified curing issues with the silicone during the needles manufacturing process.
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2023-08-29 K232313 LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) FZP Class II General, Plastic Surgery
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence