510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030031Substantially Equivalent

Soft Tissue Anchoring Washers

Accu-Speed, Incorporated, Groton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K030031 is the FDA 510(k) clearance record for SOFT TISSUE ANCHORING WASHERS, a class I device, cleared for Accu-Speed, Incorporated on under FDA product code KGS (Retention Device, Suture). FDA records list one 510(k) clearance for Accu-Speed, Incorporated. As of , FDA records show no recalls naming K030031.

Clearance record

Decision date
Received
(25 days to decision)
Product code
KGS Retention Device, Suture
Regulation
21 CFR 878.4930
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Accu-Speed, Incorporated P.O. Box 1008, 65 Gay Rd., Groton MA
510(k) summary
Statement
Third party review
No

Clearances, product code KGS

Trailing 12 months

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

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