510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980988Substantially Equivalent

Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)

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

K980988 is the FDA 510(k) clearance record for AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS), a class I device, cleared for Axya Medical, Inc. on under FDA product code GAB (Needle, Suturing, Disposable). FDA records list 140 510(k) clearances for TORNIER Inc., from to . As of , FDA records show no recalls naming K980988.

Clearance record

Decision date
Received
(55 days to decision)
Product code
GAB Needle, Suturing, Disposable
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Axya Medical, Inc. 12 S. St., Marblehead MA
510(k) summary
Summary
Third party review
No

Clearances, product code GAB

Trailing 12 months

FDA records hold no clearances under product code GAB in the trailing twelve months.

FDA records show no clearances under product code GAB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260