Cleared Special

K110829 - ACE STAPLER AND CARTRIDGE

K110829 is an FDA 510(k) clearance for ACE STAPLER AND CARTRIDGE, manufactured by Barosense, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCW cleared through the Special 510(k) pathway after a 71-day FDA review.

K110829 · Barosense, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
71d
Days
Class 2
Risk

K110829 is an FDA 510(k) clearance for the ACE STAPLER AND CARTRIDGE. 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 June 3, 2011 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Barosense, Inc. devices

FDA 510(k) Submission Details - K110829

510(k) Number K110829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2011
Decision Date June 03, 2011
Days to Decision 71 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 131d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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 61
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K110829.
MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
K132232 · Minilap Technologies · Dec 2013
WECK EFX ENDO FASCIAL CLOSURE SYSTEM
K132362 · Teleflexmedical, Inc. · Oct 2013
ACE STAPLER AND CARTRIDGE
K120147 · Barosense, Inc. · Feb 2012
AXIOM FASCIAL CLOSURE SYSTEM
K103412 · Axiom Technology Partners, LLC · Dec 2010
MINI-TONG
K101101 · Mini Lap Technologies, Inc. · Jul 2010
ACE STAPLER, MODEL F0031
K082044 · Barosense, Inc. · May 2010