510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011027Substantially Equivalent

Fortaflex Surgical Sling

Organogenesis, Inc., Canton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011027 is the FDA 510(k) clearance record for FORTAFLEX SURGICAL SLING, a class II device, cleared for Organogenesis, Inc. on under FDA product code FTM (Mesh, Surgical). FDA records list 12 510(k) clearances for Organogenesis, Inc., from to . As of , FDA records show no recalls naming K011027.

Clearance record

Decision date
Received
(55 days to decision)
Product code
FTM Mesh, Surgical
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Organogenesis, Inc. 150 Dan Rd., Canton MA
510(k) summary
Summary
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