510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K950434Substantially Equivalent

Karl Storz Flexible Grasping, Biopsy Forceps, Stone Baskets, Dislodgers, Scissors, Injection Cannulae, Cleaning Brushes

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

K950434 is the FDA 510(k) clearance record for KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered). FDA's definition for product code OCZ reads: "To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope". FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K950434.

Clearance record

Decision date
Received
(55 days to decision)
Product code
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
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 OCZ

Trailing 12 months
1 clearance under product code OCZ in the twelve months to November 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OCZ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260
November 20260