HISTOBRUSH
FDA 510(k) clearance K111681 · decided 2012-01-19
Clearance details
- K-number
- K111681
- Device name
- HISTOBRUSH
- Applicant
- Puritan Medical Products Company, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-06-15
- Decision date
- 2012-01-19
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- HHT
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Guilford, ME, 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 |
|---|---|---|
| exCellerator Cervical Collection Device (K182049) | Excell Company, LLC | 2019-04-25 |
| Kolplast Cervical Sample Collection Kit (K153128) | Kolplast CI SA | 2017-01-13 |
| DISPOSABLE CERVICAL BRUSH (K141057) | Ningbo Hls Medical Products Co., Ltd. | 2015-05-14 |
| PAPCONE (K083012) | Otto Bock Pur Life Science GmbH | 2009-04-09 |
| BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY (K081522) | Bio Nuclear Diagnostics, Inc. | 2008-12-05 |
| SOFTPAP CERVICAL CELL COLLECTOR (K072381) | Cytocore, Inc. | 2008-01-30 |
| DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM (K062433) | Diamics, Inc. | 2007-03-16 |
| CERVEX-BRUSH COMBI (K043369) | Rovers Medical Devices B.V. | 2005-02-02 |
| SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 (K042527) | Medical Action Industries, Inc. | 2004-11-08 |
| DRG SOFTRELEASE (K041018) | Doctor'S Research Group, Inc. | 2004-10-18 |
| INPATH E2 COLLECTOR (K013258) | Molecular Diagnostics | 2002-05-31 |
| ROVERS SPATULA (K002520) | Rovers Medical Devices B.V. | 2000-11-13 |
Recalls involving this device
No recalls on record reference this clearance.