Cleared Traditional

K130078 - QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

K130078 is an FDA 510(k) clearance for QUILL POLYPROPYLENE KNOTLESS TISSUE-CLO..., manufactured by Surgical Specialties Corp. Dba Angiotech. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K130078 · Surgical Specialties Corp. Dba Angiotech · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
45d
Days
Class 2
Risk

K130078 is an FDA 510(k) clearance for the QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Surgical Specialties Corp. Dba Angiotech (Reading, US). The FDA issued a Cleared decision on February 28, 2013 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - 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 - K130078

510(k) Number K130078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2013
Decision Date February 28, 2013
Days to Decision 45 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
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAW Device Classification - Class 2, Special Controls

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 80
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K130078.
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