510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011105Substantially Equivalent

Suturtek Fastclose Fascia Closure Device

Qrc Consulting, Hopkonton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011105 is the FDA 510(k) clearance record for SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE, a class II device, cleared for Qrc Consulting on under FDA product code GAL (Suture, Absorbable, Natural). FDA records list one 510(k) clearance for Qrc Consulting. As of , FDA records show no recalls naming K011105.

Clearance record

Decision date
Received
(49 days to decision)
Product code
GAL Suture, Absorbable, Natural
Regulation
21 CFR 878.4830
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Qrc Consulting 7 Tiffany Trl., Hopkonton MA
510(k) summary
Summary
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