Cleared Special

K120268 - AMID STAPLER

K120268 is an FDA 510(k) clearance for AMID STAPLER, manufactured by Safestich Medical, LLC. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Special 510(k) pathway after a 11-day FDA review.

K120268 · Safestich Medical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
11d
Days
Class 2
Risk

K120268 is an FDA 510(k) clearance for the AMID STAPLER. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Safestich Medical, LLC (Miami, US). The FDA issued a Cleared decision on February 10, 2012 after a review of 11 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.

FDA 510(k) Submission Details - K120268

510(k) Number K120268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2012
Decision Date February 10, 2012
Days to Decision 11 days
Submission Type Special
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
104d faster than avg
Panel avg: 115d · This submission: 11d
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 274
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K120268.
REACH SURGICAL STAPLERS
K120179 · Reach Surgical, Inc. · May 2012
INSORB ABSORBALBE STAPLE
K120373 · Incisive Surgical, Inc. · Mar 2012
DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS
K120258 · Covidien, Formerly US Surgical A Divison of Tyco H · Feb 2012
ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL
K112056 · Ethicon Endo-Surgery, LLC · Dec 2011
ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
K111825 · Covidien, Formerly US Surgical A Divison of Tyco H · Oct 2011
VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
K111195 · Ethicon Endo-Surgery, Inc. · Aug 2011
K120268 · AMID STAPLER
Download PDF FDA Summary Safestich Medical, LLC