Cleared Traditional

K090470 - AUTOSUTURE PROTACK

Also marketed or referenced as:
TACKER SYSTEM ABSORBATACK FIXATION DEVICES

K090470 is the FDA 510(k) clearance for AUTOSUTURE PROTACK by Covidien. It is a Class 2 General & Plastic Surgery device (product code OCW) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K090470 · Covidien · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
80d
Days
Class 2
Risk

K090470 is an FDA 510(k) clearance for the AUTOSUTURE PROTACK. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on May 14, 2009 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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 Covidien devices

Submission Details

510(k) Number K090470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2009
Decision Date May 14, 2009
Days to Decision 80 days
Submission Type Traditional
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
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCW Endoscopic Tissue Approximation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
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 - OCW Endoscopic Tissue Approximation Device

All 36
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K090470.
OverStitch Endoscopic Suturing System and Accessories
K181141 · Apollo Endosurgery · Jun 2018
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
K172775 · Teleflexmedical, Inc. · Feb 2018
WECK EFX ENDO FASCIAL CLOSURE SYSTEM
K132362 · Teleflexmedical, Inc. · Oct 2013
INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER
K070151 · Ethicon Endo-Surgery, LLC · Aug 2007
OPUS SMARTSTITCH SUTURE DEVICE
K070671 · Arthrocare Corp. · Apr 2007
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
K062244 · Arthrocare Corp. · Oct 2006