Cleared Traditional

K112763 - MATRIXBRUSH ENDOMETRIAL SAMPLER

K112763 is an FDA 510(k) clearance for MATRIXBRUSH ENDOMETRIAL SAMPLER, manufactured by Post Oak Innovations, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFE cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K112763 · Post Oak Innovations, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
270d
Days
Class 2
Risk

K112763 is an FDA 510(k) clearance for the MATRIXBRUSH ENDOMETRIAL SAMPLER. Classified as Brush, Endometrial (product code HFE), Class II - Special Controls.

Submitted by Post Oak Innovations, Inc. (Austin, US). The FDA issued a Cleared decision on June 18, 2012 after a review of 270 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1100 - the FDA obstetrics and gynecology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Post Oak Innovations, Inc. devices

FDA 510(k) Submission Details - K112763

510(k) Number K112763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2011
Decision Date June 18, 2012
Days to Decision 270 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 160d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFE Device Classification - Class 2, Special Controls

Product Code HFE Brush, Endometrial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1100
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HFE Brush, Endometrial

Devices cleared under the same product code (HFE) and FDA review panel - the closest regulatory comparables to K112763.
Utepreva Endometrial Sampler (UP01)
K240595 · Utepreva, LLC · Aug 2024
Tao Brush I.U.M.C. Endometrial Sampler
K170603 · Cook Incorporated · May 2017
TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
K082066 · Cook Urological, Inc. · Nov 2008
IUMC ENDOMETRIAL SAMPLER
K941298 · Cook Ob/Gyn · Feb 1995
STOVALL ENDOMETRIAL BRUSH
K911620 · Cook Ob/Gyn · Jun 1994