510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K960011Substantially Equivalent

Endoscopic Needle Driver

United States Surgical, A Division of Tyco Healthc, Norwalk CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960011 is the FDA 510(k) clearance record for ENDOSCOPIC NEEDLE DRIVER, a class II device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code OCW (Endoscopic Tissue Approximation Device). FDA's definition for product code OCW reads: "To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue". FDA records list 218 510(k) clearances for United States Surgical, A Division of Tyco Healthc, from to . As of , FDA records show no recalls naming K960011.

Clearance record

Decision date
Received
(50 days to decision)
Product code
OCW Endoscopic Tissue Approximation Device
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
United States Surgical, A Division of Tyco Healthc 150 Glover Ave., Norwalk CT
510(k) summary
Summary
Third party review
No

Clearances, product code OCW

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