Cleared Traditional

K082044 - ACE STAPLER

K082044 is an FDA 510(k) clearance for ACE STAPLER, manufactured by Barosense, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCW cleared through the Traditional 510(k) pathway after a 662-day FDA review.

K082044 · Barosense, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
662d
Days
Class 2
Risk

K082044 is an FDA 510(k) clearance for the ACE STAPLER, MODEL F0031. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Barosense, Inc. (Redwood City, US). The FDA issued a Cleared decision on May 11, 2010 after a review of 662 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Barosense, Inc. devices

FDA 510(k) Submission Details - K082044

510(k) Number K082044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2008
Decision Date May 11, 2010
Days to Decision 662 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
532d slower than avg
Panel avg: 130d · This submission: 662d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCW Device Classification - Class 2, Special Controls

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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCW Endoscopic Tissue Approximation Device

All 38
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K082044.
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
AUTOSUTURE PROTACK
K090470 · Covidien · May 2009
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