Cleared Traditional

K071989 - QUILL SELF-RETAINING SYSTEM (SRS) SYNTH...

K071989 is an FDA 510(k) clearance for QUILL SELF-RETAINING SYSTEM (SRS) SYNTH..., manufactured by Surgical Specialties Corp. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K071989 · Surgical Specialties Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
17d
Days
Class 2
Risk

K071989 is an FDA 510(k) clearance for the QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by Surgical Specialties Corp (Reading, US). The FDA issued a Cleared decision on August 6, 2007 after a review of 17 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. 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.

View all Surgical Specialties Corp devices

FDA 510(k) Submission Details - K071989

510(k) Number K071989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2007
Decision Date August 06, 2007
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K071989.
PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
K100461 · Riverpoint Medical · Jul 2010
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)
K080985 · Surgical Specialties Corp · Apr 2008
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
K080680 · Surgical Specialties Corp · Mar 2008
SHARPOINT PDO (POLYDIOXANONE) SUTURES
K063680 · Surgical Specialties Corp · May 2007
PDS PLUS ANTIBACTERIAL SUTURE
K061037 · Ethicon, Inc. · Jul 2006
CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
K053380 · Surgical Specialties Corp · Jan 2006