Cleared Special

K141778 - QUILL MONODERM KNOTLESS TISSUE-CLOSURE ...

K141778 is an FDA 510(k) clearance for QUILL MONODERM KNOTLESS TISSUE-CLOSURE ..., manufactured by Surgical Specialties Corporation. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Special 510(k) pathway after a 28-day FDA review.

K141778 · Surgical Specialties Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
28d
Days
Class 2
Risk

K141778 is an FDA 510(k) clearance for the QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Surgical Specialties Corporation (Reading, US). The FDA issued a Cleared decision on July 30, 2014 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Surgical Specialties Corporation devices

FDA 510(k) Submission Details - K141778

510(k) Number K141778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2014
Decision Date July 30, 2014
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

GAM Device Classification - Class 2, Special Controls

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 87
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K141778.
E-Pack Procedure Kit
K161726 · Ethicon, Inc. · Jul 2016
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
K151200 · Ethicon, Inc. · Aug 2015
PLIASURE Polyglycolide Synthetic Absorbable Suture
K142822 · Ethicon, Inc. · Mar 2015
POLYSYN SURGICAL SUTURE
K141625 · Surgical Specialties Corp · Jul 2014
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
K141558 · Surgical Specialties Corp · Jul 2014
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
K132580 · Ethicon, Inc. · Feb 2014