Product code HHT
- Device name
- Spatula, Cervical, Cytological
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4530
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182049 | exCellerator Cervical Collection Device | Excell Company, LLC | 2019-04-25 |
| K153128 | Kolplast Cervical Sample Collection Kit | Kolplast CI SA | 2017-01-13 |
| K141057 | DISPOSABLE CERVICAL BRUSH | Ningbo Hls Medical Products Co., Ltd. | 2015-05-14 |
| K111681 | HISTOBRUSH | Puritan Medical Products Company, LLC | 2012-01-19 |
| K083012 | PAPCONE | Otto Bock Pur Life Science GmbH | 2009-04-09 |
| K081522 | BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY | Bio Nuclear Diagnostics, Inc. | 2008-12-05 |
| K072381 | SOFTPAP CERVICAL CELL COLLECTOR | Cytocore, Inc. | 2008-01-30 |
| K062433 | DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM | Diamics, Inc. | 2007-03-16 |
| K043369 | CERVEX-BRUSH COMBI | Rovers Medical Devices B.V. | 2005-02-02 |
| K042527 | SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 | Medical Action Industries, Inc. | 2004-11-08 |
| K041018 | DRG SOFTRELEASE | Doctor'S Research Group, Inc. | 2004-10-18 |
| K013258 | INPATH E2 COLLECTOR | Molecular Diagnostics | 2002-05-31 |
| K002520 | ROVERS SPATULA | Rovers Medical Devices B.V. | 2000-11-13 |
| K001119 | ROVERS ENDOCERVEX-BRUSH | Rovers Medical Devices B.V. | 2000-05-19 |
| K991593 | ORIBRUSH - STANDARD - B002 | Orifice Medical AB | 1999-06-29 |
| K991595 | ORIBRUSH - WITH PROTECTIVE TIP - B001 | Orifice Medical AB | 1999-06-29 |
| K983202 | HARWILL MEDICAL CERVITULA CERVICAL SPATULA | Harwill Medical (Pty) , Ltd. | 1999-03-15 |
| K983599 | SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT | Andwin Scientific | 1998-12-11 |
| K983428 | SAFETEX CERVICAL SCRAPER (PLASTIC) | Andwin Scientific | 1998-11-16 |
| K980356 | CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010 | Canadian Medical Brush, Inc. | 1998-04-16 |
| K971586 | DIGENE CERVICAL BRUSH | Digene Corp. | 1997-09-19 |
| K971849 | CYTOLOGY BRUSH | Team Technologies, Inc. | 1997-07-24 |
| K963801 | PAP BRUSH | Young OU Brush Co. | 1997-04-09 |
| K963685 | EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER | North Eos Industries, Inc. | 1996-10-11 |
| K961934 | PURITAN FOAM TIP SWAB MODEL 2197 | Hardwood Products Co., LP | 1996-07-09 |
| K960469 | DETECT CYTOLOGY BRUSH II | Cook Urological, Inc. | 1996-03-14 |
| K954562 | GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT | Gynetech, Inc. | 1995-12-22 |
| K950780 | AMSINO CERVICAL SCRAPER | Amsino Intl., Inc. | 1995-07-25 |
| K941472 | CERVEX-BRUSH PAP KIT | Rovers Diagnostic Devices | 1995-02-28 |
| K933870 | VIBA-BRUSH | Rovers B.V. | 1995-01-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 18719189246282 | Rovers® EndoCervex-Brush® | Rovers Medical Devices B.V. | 2023-07-12 |
| 18719189246602 | Rovers® Cervex-Brush® Combi | Rovers Medical Devices B.V. | 2023-07-12 |
| 18719189246275 | Rovers® EndoCervex-Brush® | Rovers Medical Devices B.V. | 2023-07-12 |
| 18719189246268 | Rovers® Cervex-Brush® | Rovers Medical Devices B.V. | 2023-07-12 |
| 18719189246398 | Rovers® Cervex-Brush® | Rovers Medical Devices B.V. | 2023-07-12 |
| 18719189246299 | Rovers® EndoCervex-Brush®-S | Rovers Medical Devices B.V. | 2023-07-12 |
| 18719189246251 | Rovers® Viba-Brush® | Rovers Medical Devices B.V. | 2023-07-12 |
| 18719189246220 | Rovers® Viba-Brush® | Rovers Medical Devices B.V. | 2023-07-12 |
| 18719189246084 | Rovers® Cervex-Brush® Combi | Rovers Medical Devices B.V. | 2023-07-12 |
| 18719189246213 | Rovers® Viba-Brush® | Rovers Medical Devices B.V. | 2023-07-12 |
| 10810010891003 | Aero-Med | AERO-MED, LLC | 2019-01-21 |
| 10810010890495 | Aero-Med | AERO-MED, LLC | 2019-01-16 |
| 10810010890464 | Aero-Med | AERO-MED, LLC | 2019-01-16 |
| 20888937021404 | BD Surepath Sample Collection Kit | Coopersurgical, Inc. | 2018-09-21 |
| 08719189246490 | Rovers® Cervex-Brush® Combi | Rovers Medical Devices B.V. | 2018-07-09 |
| 08719189246483 | Rovers® Cervex-Brush® | Rovers Medical Devices B.V. | 2018-07-09 |
| 08719189246025 | Rovers® Cervex-Brush® | Rovers Medical Devices B.V. | 2018-07-08 |
| 08719189246100 | Rovers® EndoCervex-Brush® | Rovers Medical Devices B.V. | 2017-10-20 |
| 08719189246001 | Rovers® Cervex-Brush® | Rovers Medical Devices B.V. | 2017-10-20 |
| 50888937003173 | Cytobrush Plus | Coopersurgical, Inc. | 2016-09-21 |
| 50888937003180 | Cytobrush Plus | Coopersurgical, Inc. | 2016-09-21 |
| 50888937003197 | Cytobrush Plus | Coopersurgical, Inc. | 2016-09-21 |
| 50888937003203 | Cytobrush Plus GT | Coopersurgical, Inc. | 2016-09-21 |
| 50888937003210 | Cytobrush Plus GT | Coopersurgical, Inc. | 2016-09-21 |
| 10609576250092 | Rovers EndoCervex Brush | Puritan Medical Products | 2016-09-07 |
| 30609576250065 | CerfiSoft Foam Cytology Collection Swab | Puritan Medical Products | 2016-09-07 |
| 30609576250089 | Histobrush® Cytology Brush | Puritan Medical Products | 2016-09-07 |
| M36816011 | Grafco | GF HEALTH PRODUCTS, INC. | 2016-08-31 |
| 50888937001193 | Spatula | Coopersurgical, Inc. | 2016-03-21 |
| 50888937001209 | Spatula | Coopersurgical, Inc. | 2016-03-21 |