510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091018Substantially Equivalent

Arthrex Biowire

Arthrex GmbH, Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091018 is the FDA 510(k) clearance record for ARTHREX BIOWIRE, a class II device, cleared for Arthrex, Inc. on under FDA product code GAS (Suture, Nonabsorbable, Synthetic, Polyester). FDA records list 352 510(k) clearances for Arthrex, Inc., from to . As of , FDA records show no recalls naming K091018.

Clearance record

Decision date
Received
(477 days to decision)
Product code
GAS Suture, Nonabsorbable, Synthetic, Polyester
Regulation
21 CFR 878.5000
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Arthrex, Inc. 1370 Creekside Blvd., Naples FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAS

Trailing 12 months

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

FDA records show no clearances under product code GAS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAS, 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