510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K960219Substantially Equivalent

Prolex Mesh

Advanced Surgical Innovations, Inc., Mississauga, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960219 is the FDA 510(k) clearance record for PROLEX MESH, a class II device, cleared for Advanced Surgical Innovations, Inc. on under FDA product code FTL (Mesh, Surgical, Polymeric). FDA records list one 510(k) clearance for Advanced Surgical Innovations, Inc. As of , FDA records show no recalls naming K960219.

Clearance record

Decision date
Received
(59 days to decision)
Product code
FTL Mesh, Surgical, Polymeric
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Advanced Surgical Innovations, Inc. 6890 Pacific Cir., Mississauga, Ontario, CA
510(k) summary
Statement
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