510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080691Substantially Equivalent

C-Qur Edge Mesh V-Patch

Atrium Medical Corporation, Hudson NH / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K080691 is the FDA 510(k) clearance record for C-QUR EDGE MESH V-PATCH, a class II device, cleared for Atrium Medical Corp. on under FDA product code FTL (Mesh, Surgical, Polymeric). FDA records list 69 510(k) clearances for Atrium Medical Corp., from to . As of , FDA records show no recalls naming K080691.

Clearance record

Decision date
Received
(36 days to decision)
Product code
FTL Mesh, Surgical, Polymeric
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Atrium Medical Corp. 5 Wentworth Dr., Hudson NH
510(k) summary
Statement
Third party review
No

Clearances, product code FTL

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