The following data is part of a premarket notification filed by Post Oak Innovations, Inc. with the FDA for Matrixbrush Endometrial Sampler.
| Device ID | K112763 |
| 510k Number | K112763 |
| Device Name: | MATRIXBRUSH ENDOMETRIAL SAMPLER |
| Classification | Brush, Endometrial |
| Applicant | POST OAK INNOVATIONS, INC. 9433 BEE CAVES ROAD BUILDING 1, SUITE 140 Austin, TX 78733 |
| Contact | Heather Crawford |
| Correspondent | Heather Crawford POST OAK INNOVATIONS, INC. 9433 BEE CAVES ROAD BUILDING 1, SUITE 140 Austin, TX 78733 |
| Product Code | HFE |
| CFR Regulation Number | 884.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-22 |
| Decision Date | 2012-06-18 |
| Summary: | summary |