510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171357Substantially Equivalent

SurgiMend PRS Meshed, Revize-X

Integra Lifesciences Corporation (Owner of Tei Biosciences), Boston MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171357 is the FDA 510(k) clearance record for SurgiMend PRS Meshed, Revize-X, a class II device, cleared for Integra Lifesciences Corporation (Owner of Tei Biosciences) on under FDA product code OXH (Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery). FDA's definition for product code OXH reads: "For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery". FDA records list one 510(k) clearance for Integra Lifesciences Corporation (Owner of Tei Biosciences). As of , FDA records show 2 recalls naming K171357.

Clearance record

Decision date
Received
(29 days to decision)
Product code
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Integra Lifesciences Corporation (Owner of Tei Biosciences) 7 Elkins St., Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OXH

Trailing 12 months

FDA records hold no clearances under product code OXH in the trailing twelve months.

FDA records show no clearances under product code OXH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OXH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260