Cleared Special

K120373 - INSORB ABSORBALBE STAPLE

K120373 is an FDA 510(k) clearance for INSORB ABSORBALBE 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 39-day FDA review.

K120373 · Incisive Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
39d
Days
Class 2
Risk

K120373 is an FDA 510(k) clearance for the INSORB ABSORBALBE STAPLE. 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 March 16, 2012 after a review of 39 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 - K120373

510(k) Number K120373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2012
Decision Date March 16, 2012
Days to Decision 39 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
76d faster than avg
Panel avg: 115d · This submission: 39d
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
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