Cleared Traditional

K011105 - SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE

K011105 is an FDA 510(k) clearance for SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE, manufactured by Qrc Consulting. The device is a Class 2 General & Plastic Surgery device with product code GAL cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K011105 · Qrc Consulting · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
49d
Days
Class 2
Risk

K011105 is an FDA 510(k) clearance for the SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE. Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by Qrc Consulting (Hopkonton, US). The FDA issued a Cleared decision on May 30, 2001 after a review of 49 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4830 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K011105

510(k) Number K011105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2001
Decision Date May 30, 2001
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAL Device Classification - Class 2, Special Controls

Product Code GAL Suture, Absorbable, Natural
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4830
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAL Suture, Absorbable, Natural

All 29
Devices cleared under the same product code (GAL) and FDA review panel - the closest regulatory comparables to K011105.
SUTURTEK FASTCLOSE SUTURING DEVICE
K030227 · Suturtek Incorporated · Mar 2003
SERRALGUT
K020597 · Serral, S.A. DE C.V. · Aug 2002
GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
K021043 · Gramsmed, LLC · Jun 2002
PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP
K001299 · Cp Medical · Jun 2000
PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
K000542 · Arc Medical Supplies (Beijing) Co, Ltd. · Apr 2000
LIGA-LOOP SUTURE APPLICATOR
K993695 · Hysterx, Inc. · Apr 2000
K011105 · SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
Download PDF FDA Summary Qrc Consulting