Cleared Traditional

K071061 - ABSORBATACK AND APPLICATOR

K071061 is an FDA 510(k) clearance for ABSORBATACK AND APPLICATOR, manufactured by Sorbx, LLC. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K071061 · Sorbx, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
30d
Days
Class 2
Risk

K071061 is an FDA 510(k) clearance for the ABSORBATACK AND APPLICATOR. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Sorbx, LLC (Ponte Vedra Beach, US). The FDA issued a Cleared decision on May 16, 2007 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 878.4750 - 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 Sorbx, LLC devices

FDA 510(k) Submission Details - K071061

510(k) Number K071061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2007
Decision Date May 16, 2007
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
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.

GDW Device Classification - Class 2, Special Controls

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 - GDW Staple, Implantable

All 189
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K071061.
AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
K071920 · United States Surgical, A Division of Tyco Healthc · Sep 2007
I45, I45S, I60, AND I60S
K071708 · Power Medical Interventions, Inc. · Sep 2007
ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)
K070887 · Ethicon Endo-Surgery, LLC · May 2007
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G, CR40B AND CR40G
K062869 · Ethicon Endo-Surgery, LLC · Feb 2007
POWER EXTENDERS MODEL# PEC200, PES200,PES200S
K063746 · Power Medical Interventions, Inc. · Jan 2007
NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS
K063075 · Power Medical Interventions, Inc. · Nov 2006