510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223052Substantially Equivalent

Peri-Guard and Supple Peri-Guard

Synovis Life Technologies, Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223052 is the FDA 510(k) clearance record for Peri-Guard and Supple Peri-Guard, a class II device, cleared for Synovis Life Technologies, Inc. on under FDA product code FTM (Mesh, Surgical). FDA records list 9 510(k) clearances for Synovis Life Technologies, Inc., from to . As of , FDA records show 4 recalls naming K223052.

Clearance record

Decision date
Received
(190 days to decision)
Product code
FTM Mesh, Surgical
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Synovis Life Technologies, Inc. A Subsidiary Of Baxter International Inc.), St. Paul MN
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