510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073219Substantially Equivalent

Wmt Collagen Dermal Matrix, 4 Cm X 7 Cm, Model 89Xm-4X07, Vmt Collagen Dermal Matrix, 6 Cm X 8 Cm, Model 89Xm-6X08

American Medical Systems, Inc., Minnetonka MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073219 is the FDA 510(k) clearance record for WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08, a class II device, cleared for American Medical Systems, Inc. on under FDA product code FTM (Mesh, Surgical). FDA records list 82 510(k) clearances for American Medical Systems, Inc., from to . As of , FDA records show no recalls naming K073219.

Clearance record

Decision date
Received
(147 days to decision)
Product code
FTM Mesh, Surgical
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
American Medical Systems, Inc. 10700 Bren Rd. W., Minnetonka 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