Chrysalis Intelligence · Sponsors · KARL STORZ Endoscopy-America, Inc.

KARL STORZ Endoscopy-America, Inc.

El Segundo, CA, US · 6 510(k) clearances · 17 PMAs

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Total clearances
6
2020-08-11 → 2026-05-15
Last 12 months
1
Product codes
6
Most recent
2026-05-15
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
EQN — — — 1 2026-05-15
GCJ Laparoscope, General & Plastic Surgery Class II Gastroenterology, Urology 1 2023-03-30
FAJ Cystoscope And Accessories, Flexible/Rigid Class II Gastroenterology, Urology 1 2020-10-29
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Class II Ear, Nose, Throat 1 2020-10-22
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Class II Gastroenterology, Urology 1 2020-09-01
EOB Nasopharyngoscope (Flexible Or Rigid) Class II Ear, Nose, Throat 1 2020-08-11
Class III

PMA approvals (17)

Total PMA records
17
Originals + supplements
Distinct product codes
1
First decision
2020-03-25
Most recent
2026-07-21
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-21 P050027-S036 Photodynamic Diagnostic D-Light C System 30-Day Notice OAY Light Source System, Diagnostic Endoscopic Unknown
2026-02-26 P050027-S035 Photodynamic Diagnostic D-Light C (PDD) System Special (Immediate Track) OAY Light Source System, Diagnostic Endoscopic Unknown
2025-10-01 P050027-S034 Photodynamic Diagnostic D-Light C System 30-Day Notice OAY Light Source System, Diagnostic Endoscopic Unknown
2025-05-02 P050027-S033 KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System 30-Day Notice OAY Light Source System, Diagnostic Endoscopic Unknown
2024-09-27 P050027-S032 KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System 30-Day Notice OAY Light Source System, Diagnostic Endoscopic Unknown
2023-05-05 P050027-S031 KARL STORZ D-Light C PDD System 30-Day Notice OAY Light Source System, Diagnostic Endoscopic Unknown
2022-03-17 P050027-S030 KARL STORZ D-Light C PDD System 30-Day Notice OAY Light Source System, Diagnostic Endoscopic Unknown
2022-02-04 P050027-S028 KARL STORZ D-Light C PDD System Normal 180 Day Track OAY Light Source System, Diagnostic Endoscopic Unknown
2021-10-13 P050027-S029 KARL STORZ D-Light C PDD System 30-Day Notice OAY Light Source System, Diagnostic Endoscopic Unknown
2021-01-08 P050027-S027 D-Light C PDD System 30-Day Notice OAY Light Source System, Diagnostic Endoscopic Unknown
2021-01-06 P050027-S026 KARL STORZ Photodynamic Diagnostic (PDD) D-Light System 30-Day Notice OAY Light Source System, Diagnostic Endoscopic Unknown
2020-08-17 P050027-S024 KARL STORZ Photodynamic D-Light C PDD System Real-Time Process OAY Light Source System, Diagnostic Endoscopic Unknown
2020-08-17 P050027-S023 KARL STORZ Photodynamic D-Light C PDD System Real-Time Process OAY Light Source System, Diagnostic Endoscopic Unknown
2020-08-17 P050027-S022 KARL STORZ Photodynamic D-Light C PDD System Real-Time Process OAY Light Source System, Diagnostic Endoscopic Unknown
2020-07-29 P050027-S025 KARL STORZ Photodynamic Diagnostic (PDD) D-Light C System 30-Day Notice OAY Light Source System, Diagnostic Endoscopic Unknown
2020-06-05 P050027-S021 KARL STORZ Photodynamic D-Light C PDD System 30-Day Notice OAY Light Source System, Diagnostic Endoscopic Unknown
2020-03-25 P050027-S020 KARL STORZ Photodynamic Diagnostic D-Light C System 30-Day Notice OAY Light Source System, Diagnostic Endoscopic Unknown
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2026-05-15 K252624 KARL STORZ Laryngoscopes and Accessories EQN — —
2023-03-30 K223923 HOPKINS Telescopes GCJ Class II Gastroenterology, Urology
2020-10-29 K202957 Flexible Video Cysto-Urethroscope (C-view) FAJ Class II Gastroenterology, Urology
2020-10-22 K200318 UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece ERL Class II Ear, Nose, Throat
2020-09-01 K201135 Image1 S CCU, Image1 S 4U Camera Head FET Class II Gastroenterology, Urology
2020-08-11 K200740 HD Video Rhino Laryngoscope EOB Class II Ear, Nose, Throat
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence