510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K960323Substantially Equivalent

Karl Storz Gelet Uretero-Renoscopes/karl Storz Alken Motion Control Device

Karl Storz Endoscopy-America, Inc., Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960323 is the FDA 510(k) clearance record for KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code FGB (Ureteroscope And Accessories, Flexible/Rigid). FDA's definition for product code FGB reads: "To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k)...". FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K960323.

Clearance record

Decision date
Received
(90 days to decision)
Product code
FGB Ureteroscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
KARL STORZ Endoscopy-America, Inc. 600 Corporate Pt.e, Culver City CA
510(k) summary
Summary
Third party review
No

Clearances, product code FGB

Trailing 12 months
11 clearances under product code FGB in the twelve months to November 2026, August 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FGB, trailing twelve months
MonthClearances
December 20252
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20261
August 20263
September 20262
October 20261
November 20260