510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042367Substantially Equivalent

Nylon Threaded Needle

Aros Surgical Instruments Corporation, Irvine CA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042367 is the FDA 510(k) clearance record for NYLON THREADED NEEDLE, a class II device, cleared for Aros Surgical Instruments Corp. on under FDA product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide). FDA records list 2 510(k) clearances for Aros Surgical Instruments Corp., from to . As of , FDA records show no recalls naming K042367.

Clearance record

Decision date
Received
(44 days to decision)
Product code
GAR Suture, Nonabsorbable, Synthetic, Polyamide
Regulation
21 CFR 878.5020
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Aros Surgical Instruments Corp. 3722 Ave. Sausalito, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAR

Trailing 12 months
1 clearance under product code GAR in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GAR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260