Cleared Traditional

K093253 - AMID STAPLER

K093253 is an FDA 510(k) clearance for AMID STAPLER, manufactured by Safestitch, LLC. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K093253 · Safestitch, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
27d
Days
Class 2
Risk

K093253 is an FDA 510(k) clearance for the AMID STAPLER. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Safestitch, LLC (Coral Springs, US). The FDA issued a Cleared decision on November 12, 2009 after a review of 27 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.

FDA 510(k) Submission Details - K093253

510(k) Number K093253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2009
Decision Date November 12, 2009
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
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 281
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K093253.
ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
K093845 · Ethicon, Inc. · Apr 2010
DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32
K100386 · Changzhou Waston Medical Appliance Co., Ltd. · Mar 2010
BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
K092483 · C.R. Bard, Inc. · Dec 2009
AUTOSUTURE EEA ORVIL
K093402 · Surgical Devices, A Global Business Unit Tyco · Nov 2009
AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY
K093410 · Surgical Devices, A Divsion of Tyco Healthcare · Nov 2009
ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)
K092577 · Ethicon Endo-Surgery, LLC · Sep 2009
K093253 · AMID STAPLER
Download PDF FDA Summary Safestitch, LLC