510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030227Substantially Equivalent

Suturtek Fastclose Suturing Device

Suturtek Incorporated, Hopkonton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030227 is the FDA 510(k) clearance record for SUTURTEK FASTCLOSE SUTURING DEVICE, a class II device, cleared for Suturtek Incorporated on under FDA product code GAL (Suture, Absorbable, Natural). FDA records list 4 510(k) clearances for Suturtek Incorporated, from to . As of , FDA records show no recalls naming K030227.

Clearance record

Decision date
Received
(54 days to decision)
Product code
GAL Suture, Absorbable, Natural
Regulation
21 CFR 878.4830
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Suturtek Incorporated 7 Tiffany Trl., Hopkonton MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAL

Trailing 12 months

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

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