Chrysalis Intelligence · Sponsors · Karl Storz Endoscopy America

Karl Storz Endoscopy America

El Segundo, CA, US · 20 510(k) clearances

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Total clearances
20
2020-06-23 → 2024-10-22
Last 12 months
0
Product codes
14
Most recent
2024-10-22
Name variants in FDA filings: Karl Storz Endoscopy America / Karl Storz Endoscopy America, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GCJ Laparoscope, General & Plastic Surgery Class II Gastroenterology, Urology 4 2023-06-23
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Class II General Hospital 3 2021-07-06
EWY Mediastinoscope, Surgical Class II Ear, Nose, Throat 2 2022-06-23
OCV Endoscope Holder Class II Gastroenterology, Urology 1 2024-10-22
HIH Hysteroscope (And Accessories) Class II Obstetrics/Gynecology 1 2023-09-14
FJL Resectoscope Class II Gastroenterology, Urology 1 2023-03-17
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Class II Gastroenterology, Urology 1 2022-05-13
FGB — — — 1 2022-01-20
EOQ Bronchoscope (Flexible Or Rigid) Class II Ear, Nose, Throat 1 2021-12-29
OWN Confocal Optical Imaging Class II Gastroenterology, Urology 1 2021-11-15
FAJ Cystoscope And Accessories, Flexible/Rigid Class II Gastroenterology, Urology 1 2021-09-03
LNS Lithotriptor, Extracorporeal Shock-Wave, Urological Class II Gastroenterology, Urology 1 2021-03-30
JAA System, X-Ray, Fluoroscopic, Image-Intensified Class II Radiology 1 2020-12-29
FCX — — — 1 2020-06-23
Filings

All 510(k) clearances (20)

Date K-number Device Code Class Specialty
2024-10-22 K240506 KARL STORZ Holders OCV Class II Gastroenterology, Urology
2023-09-14 K223885 HOPKINS Telescopes HIH Class II Obstetrics/Gynecology
2023-06-23 K230359 KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- GCJ Class II Gastroenterology, Urology
2023-03-17 K221893 KARL STORZ Bipolar Resectoscopes with HF Cable FJL Class II Gastroenterology, Urology
2022-12-20 K221004 HOPKINS Telescopes GCJ Class II Gastroenterology, Urology
2022-11-10 K222504 H1 GCJ Class II Gastroenterology, Urology
2022-06-23 K213194 HD Mediastinoscope EWY Class II Ear, Nose, Throat
2022-05-13 K221174 Telepack + FET Class II Gastroenterology, Urology
2022-01-20 K212458 Flexible Video-Uretero-Renoscope SSU System FGB — —
2021-12-29 K212656 Flexible Intubation Video Endoscope – Sterile (FIVE-S) EOQ Class II Ear, Nose, Throat
2021-11-15 K212695 KARL STORZ ICG Imaging System OWN Class II Gastroenterology, Urology
2021-09-03 K212476 KARL STORZ Flexible HD Cysto-Urethroscope System FAJ Class II Gastroenterology, Urology
2021-07-06 K203198 KARL STORZ Metal Sterilization Trays KCT Class II General Hospital
2021-05-11 K202272 HD Mediastinoscope EWY Class II Ear, Nose, Throat
2021-05-07 K203572 Karl Storz Radel Sterilization Trays KCT Class II General Hospital
2021-03-30 K201001 Modulith SLX-F2 LNS Class II Gastroenterology, Urology
2021-02-25 K201945 KARL STORZ UDEL Sterilization Trays KCT Class II General Hospital
2020-12-29 K200965 XR-MX/1000 JAA Class II Radiology
2020-11-20 K201526 TIPCAM1 Rubina Video Endoscope System GCJ Class II Gastroenterology, Urology
2020-06-23 K201096 CO2mbiLED FCX — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence