MATRIXBRUSH ENDOMETRIAL SAMPLER
FDA 510(k) clearance K112763 · decided 2012-06-18
Clearance details
- K-number
- K112763
- Device name
- MATRIXBRUSH ENDOMETRIAL SAMPLER
- Applicant
- Post Oak Innovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-09-22
- Decision date
- 2012-06-18
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- HFE
- Device class
- 2
- Regulation number
- 884.1100
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Utepreva Endometrial Sampler (UP01) (K240595) | Utepreva, LLC | 2024-08-14 |
| Tao Brush I.U.M.C. Endometrial Sampler (K170603) | Cook Incorporated | 2017-05-24 |
| TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER (K082066) | Cook Urological, Inc. | 2008-11-07 |
| IUMC ENDOMETRIAL SAMPLER (K941298) | Cook Ob/Gyn | 1995-02-13 |
| STOVALL ENDOMETRIAL BRUSH (K911620) | Cook Ob/Gyn | 1994-06-24 |
| ENDOBRUSH(TM) DEVICE; OMNIBRUSH (K897070) | Intl. Cytobrush, Inc. | 1990-09-10 |
| ENDOCYTE, DISPOSABLE ENDOMETRIAL SAMPLER (K881220) | Laboratoire Ccd C/O Washington Regulatory Services | 1988-06-14 |
| ENDOCYTE (K843941) | Gyneco, Inc. | 1985-02-25 |
Recalls involving this device
No recalls on record reference this clearance.