510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162965Substantially Equivalent

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction

Integra LifeSciences Braintree Inc., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162965 is the FDA 510(k) clearance record for SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction, a class II device, cleared for Tei Biosciences, Inc. on under FDA product code FTM (Mesh, Surgical). FDA records list 16 510(k) clearances for Integra LifeSciences Braintree Inc., from to . As of , FDA records show one recall naming K162965.

Clearance record

Decision date
Received
(115 days to decision)
Product code
FTM Mesh, Surgical
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Tei Biosciences, Inc. 7 Elkins St., Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTM

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