510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K951060Substantially Equivalent

Karl Storz Koh Needle Holders, Forceps for Suturing, Suture Scissors, Tissue Probes, Injection Needle, Irrigation Instrn

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

K951060 is the FDA 510(k) clearance record for KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRN, a class II device, cleared for KARL STORZ Endoscopy-America, Inc. on under FDA product code GCJ (Laparoscope, General & Plastic Surgery). FDA's definition for product code GCJ reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 402 510(k) clearances for KARL STORZ Endoscopy-America, Inc., from to . As of , FDA records show no recalls naming K951060.

Clearance record

Decision date
Received
(14 days to decision)
Product code
GCJ Laparoscope, General & Plastic Surgery
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 GCJ

Trailing 12 months
26 clearances under product code GCJ in the twelve months to November 2026, February 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code GCJ, trailing twelve months
MonthClearances
December 20250
January 20263
February 20264
March 20260
April 20263
May 20264
June 20264
July 20263
August 20262
September 20262
October 20261
November 20260