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510(k) K011105

SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE by Qrc Consulting — Product Code GAL

K011105 is an FDA 510(k) premarket notification submitted by Qrc Consulting for the device "SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE". The FDA issued a decision of Substantially Equivalent on May 30, 2001. The device falls under product code GAL (Suture, Absorbable, Natural), a Class II device regulated under 21 CFR 878.4830.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2001
Date Received
April 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Natural
Device Class
Class II
Regulation Number
878.4830
Review Panel
SU
Submission Type

Other clearances for product code GAL

  • K142656 — Surgical Gut Suture (January 29, 2015)
  • K072930 — DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT (April 30, 2008)
  • K042287 — UNIPLAIN & UNICHROM (September 7, 2005)
  • K042897 — AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE (November 19, 2004)
  • K030227 — SUTURTEK FASTCLOSE SUTURING DEVICE (March 17, 2003)
  • K020597 — SERRALGUT (August 14, 2002)
  • K021043 — GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (June 21, 2002)
  • K001299 — PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP (June 23, 2000)
  • K000542 — PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP (April 28, 2000)
  • K993695 — LIGA-LOOP SUTURE APPLICATOR (April 13, 2000)

FDA data resources