510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112763Substantially Equivalent

Matrixbrush Endometrial Sampler

Post Oak Innovations, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112763 is the FDA 510(k) clearance record for MATRIXBRUSH ENDOMETRIAL SAMPLER, a class II device, cleared for Post Oak Innovations, Inc. on under FDA product code HFE (Brush, Endometrial). FDA records list one 510(k) clearance for Post Oak Innovations, Inc. As of , FDA records show no recalls naming K112763.

Clearance record

Decision date
Received
(270 days to decision)
Product code
HFE Brush, Endometrial
Regulation
21 CFR 884.1100
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Post Oak Innovations, Inc. 9433 Bee Caves Rd., Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HFE

Trailing 12 months

FDA records hold no clearances under product code HFE in the trailing twelve months.

FDA records show no clearances under product code HFE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HFE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260