510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K103568Substantially Equivalent

Restorelle Polypropylene Mesh; Restorelle Polypropylene Mesh

MEDLINE INDUSTRIES, LP - Northfield, Plymouth MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103568 is the FDA 510(k) clearance record for RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH, a class II device, cleared for Coloplast A/S on under FDA product code FTL (Mesh, Surgical, Polymeric). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show one recall naming K103568.

Clearance record

Decision date
Received
(16 days to decision)
Product code
FTL Mesh, Surgical, Polymeric
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Coloplast A/S 1601 W. River Rd. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTL

Trailing 12 months
2 clearances 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 20261
October 20260