Cleared Traditional

K050548 - CONTOUR MIDFACE OPPOSING UNI-DIRECTIONA...

K050548 is an FDA 510(k) clearance for CONTOUR MIDFACE OPPOSING UNI-DIRECTIONA..., manufactured by Surgical Specialties Corp. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K050548 · Surgical Specialties Corp · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
30d
Days
Class 2
Risk

K050548 is an FDA 510(k) clearance for the CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Surgical Specialties Corp (Reading, US). The FDA issued a Cleared decision on April 1, 2005 after a review of 30 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.

View all Surgical Specialties Corp devices

FDA 510(k) Submission Details - K050548

510(k) Number K050548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2005
Decision Date April 01, 2005
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 33
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K050548.
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
K133356 · Ethicon, Inc. · Dec 2013
OPTIMIZED BARB DESIGN
K052962 · Surgical Specialties Corp · Dec 2005
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
K050947 · United States Surgical, A Division of Tyco Healthc · Jun 2005
CONTOUR NECKLIFT THREADS
K050247 · Surgical Specialties Corp · Mar 2005
CONTOUR FOREHEAD/BROWLIFT THREAD
K042856 · Surgical Specialties Corp · Dec 2004
FEATHERLIFT EXTENDED LENGTH APTOS THREAD
K041593 · Surgical Specialties Corp · Sep 2004