510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K061770Substantially Equivalent

Ethicon Endo Surgery Endoscopic Suturing System

Ethicon Endo-Surgery Inc, Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061770 is the FDA 510(k) clearance record for ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM, a class II device, cleared for Ethicon Endo-Surgery, Inc. 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 185 510(k) clearances for Ethicon Endo-Surgery, Inc., from to . As of , FDA records show no recalls naming K061770.

Clearance record

Decision date
Received
(94 days to decision)
Product code
OCW Endoscopic Tissue Approximation Device
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ethicon Endo-Surgery, Inc. 4545 Creek Rd., Cincinnati OH
510(k) summary
Summary PDF
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