510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K831648Substantially Equivalent

Anchor Brand Surgical Needles

Anchor Products Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831648 is the FDA 510(k) clearance record for ANCHOR BRAND SURGICAL NEEDLES, a class I device, cleared for Anchor Products Co. on under FDA product code GAB (Needle, Suturing, Disposable). FDA records list 7 510(k) clearances for Anchor Products Co., from to . As of , FDA records show no recalls naming K831648.

Clearance record

Decision date
Received
(85 days to decision)
Product code
GAB Needle, Suturing, Disposable
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Anchor Products Co. 803 N. Front St. Suite 3, Mchenry IL
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