510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002639Substantially Equivalent

Bioknotless Anchor

Mitek Products, Norwood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002639 is the FDA 510(k) clearance record for BIOKNOTLESS ANCHOR, a class II device, cleared for Mitek Products on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list 30 510(k) clearances for Mitek Products, from to . As of , FDA records show 2 recalls naming K002639.

Clearance record

Decision date
Received
(260 days to decision)
Product code
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulation
21 CFR 878.4493
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Mitek Products 249 Vanderbilt Ave., Norwood MA
510(k) summary
Summary
Third party review
No

Clearances, product code GAM

Trailing 12 months
5 clearances under product code GAM in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GAM, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260