Cleared Special

K061784 - INSORB ABSORBABLE STAPLE, MODEL 1020

K061784 is an FDA 510(k) clearance for INSORB ABSORBABLE STAPLE, manufactured by Incisive Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Special 510(k) pathway after a 30-day FDA review.

K061784 · Incisive Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
30d
Days
Class 2
Risk

K061784 is an FDA 510(k) clearance for the INSORB ABSORBABLE STAPLE, MODEL 1020. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Incisive Surgical, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 26, 2006 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. 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 Incisive Surgical, Inc. devices

FDA 510(k) Submission Details - K061784

510(k) Number K061784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2006
Decision Date July 26, 2006
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 185
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K061784.
NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS
K063075 · Power Medical Interventions, Inc. · Nov 2006
AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
K062850 · United States Surgical, A Division of Tyco Healthc · Oct 2006
POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH
K061649 · Power Medical Interventions, Inc. · Sep 2006
ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS
K061156 · Ethicon Endo-Surgery, Inc. · Jul 2006
AUTO SUTUR ENDO GIA STAPLERS
K061095 · United States Surgical, A Division of Tyco Healthc · May 2006
CONTOUR TRANSTAR CURVED CUTTER STAPLER SET
K053631 · Ethicon Endo-Surgery, Inc. · Jan 2006