KARL STORZ Endoscopy-America, Inc.

FDA 510(k) & PMA Approved Devices — 355 products

Total Devices355

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K252624	KARL STORZ Laryngoscopes and Accessories	EQN	2026-05-15	View
510(k)	K240506	KARL STORZ Holders	OCV	2024-10-22	View
510(k)	K223885	HOPKINS Telescopes	HIH	2023-09-14	View
510(k)	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	2023-06-23	View
510(k)	K223520	UNIDRIVE SIII System	HIH	2023-04-27	View
510(k)	K223923	HOPKINS Telescopes	GCJ	2023-03-30	View
510(k)	K221893	KARL STORZ Bipolar Resectoscopes with HF Cable	FJL	2023-03-17	View
510(k)	K221004	HOPKINS Telescopes	GCJ	2022-12-20	View
510(k)	K222504	H1	GCJ	2022-11-10	View
510(k)	K213194	HD Mediastinoscope	EWY	2022-06-23	View
510(k)	K221174	Telepack +	FET	2022-05-13	View
510(k)	K212476	KARL STORZ Flexible HD Cysto-Urethroscope System	FAJ	2021-09-03	View
510(k)	K203198	KARL STORZ Metal Sterilization Trays	KCT	2021-07-06	View
510(k)	K202272	HD Mediastinoscope	EWY	2021-05-11	View
510(k)	K203572	Karl Storz Radel Sterilization Trays	KCT	2021-05-07	View
510(k)	K201945	KARL STORZ UDEL Sterilization Trays	KCT	2021-02-25	View
510(k)	K200965	XR-MX/1000	JAA	2020-12-29	View
510(k)	K202925	KARL STORZ ICG Imaging System	OWN	2020-12-17	View
510(k)	K202957	Flexible Video Cysto-Urethroscope (C-view)	FAJ	2020-10-29	View
510(k)	K200318	UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece	ERL	2020-10-22	View