510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K043191Substantially Equivalent

Repol Angimesh, Angimesh Pre, Folded Mesh, Repol Plug Basic, Repol Plug Cap, Repol Plug Flower and Wings Mesh

Angiologica B. M. SRL, San Martino Siccomario, Pavia, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043191 is the FDA 510(k) clearance record for REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH, a class II device, cleared for Angiologica B. M. Srl on under FDA product code FTL (Mesh, Surgical, Polymeric). FDA records list 2 510(k) clearances for Angiologica B. M. Srl, from to . As of , FDA records show no recalls naming K043191.

Clearance record

Decision date
Received
(180 days to decision)
Product code
FTL Mesh, Surgical, Polymeric
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Angiologica B. M. Srl 4, Via Giovanni Xxiii, San Martino Siccomario, Pavia, IT
510(k) summary
Summary PDF
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