510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K070151Substantially Equivalent

Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element Applier

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

K070151 is the FDA 510(k) clearance record for INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER, a class II device, cleared for Ethicon Endo-Surgery, LLC 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, LLC, from to . As of , FDA records show no recalls naming K070151.

Clearance record

Decision date
Received
(211 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, LLC 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