Cleared Special

K080985 - QUILL SELF-RETAINING SYSTEM (SRS) COMPR...

K080985 is an FDA 510(k) clearance for QUILL SELF-RETAINING SYSTEM (SRS) COMPR..., manufactured by Surgical Specialties Corp. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Special 510(k) pathway after a 16-day FDA review.

K080985 · Surgical Specialties Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
16d
Days
Class 2
Risk

K080985 is an FDA 510(k) clearance for the QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO). Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Surgical Specialties Corp (Herndon, US). The FDA issued a Cleared decision on April 23, 2008 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4840 - 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 Corp devices

FDA 510(k) Submission Details - K080985

510(k) Number K080985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2008
Decision Date April 23, 2008
Days to Decision 16 days
Submission Type Special
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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

NEW Device Classification - Class 2, Special Controls

Product Code NEW Suture, Surgical, Absorbable, Polydioxanone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4840
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 - NEW Suture, Surgical, Absorbable, Polydioxanone

All 35
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K080985.
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
K120284 · Coloplast A/S · May 2012
PDS(TM) BARBED SUTURES
K113004 · Ethicon, Inc. · Dec 2011
PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
K100461 · Riverpoint Medical · Jul 2010
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
K080680 · Surgical Specialties Corp · Mar 2008
QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL
K071989 · Surgical Specialties Corp · Aug 2007
SHARPOINT PDO (POLYDIOXANONE) SUTURES
K063680 · Surgical Specialties Corp · May 2007