510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K252906Substantially Equivalent

ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)

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

K252906 is the FDA 510(k) clearance record for ECHELON ENDOPATH Staple Line Reinforcement (ECH60R), a class II device, cleared for Ethicon Endo-Surgery, LLC on under FDA product code OXC (Mesh, Surgical, Absorbable, Staple Line Reinforcement). FDA's definition for product code OXC reads: "For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures". FDA records list 185 510(k) clearances for Ethicon Endo-Surgery, LLC, from to . As of , FDA records show no recalls naming K252906.

Clearance record

Decision date
Received
(119 days to decision)
Product code
OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Ethicon Endo-Surgery, LLC 475 Calle C , Pr United States, Guaynabo PR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OXC

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