Spatula, Cervical, Cytological
FDA product code HHT · Class II (moderate risk) · 21 CFR 884.4530 · Obstetrics/Gynecology
73510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Surgipath Medical Industries, Inc. 3
- Intl. Cytobrush, Inc. 3
- Rovers Medical Devices B.V. 3
- Ortho Diagnostic Systems, Inc. 2
- Birchwood Laboratories, Inc. 2
- Rovers B.V. 2
- Rovers Diagnostic Devices 2
- Anderson Winn Paper Co. 2
- A & A Medical, Inc. 2
- Orifice Medical AB 2
- Medical Packaging Corp. 2
- Andwin Scientific 2
- Medline Industries, LP 1
- Spectrum Co. 1
- Milex Products, Inc. 1
- Excell Company, LLC 1
- Tridak Division of Indicon, Inc. 1
- Donald G. Zeller 1
- Kimberly-Clark Corp. 1
- Laboratoire Ccd C/O Washington Regulatory Services 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182049 | exCellerator Cervical Collection DeviceHHT · Traditional | Excell Company, LLC | 04/25/2019SE |
| K153128 | Kolplast Cervical Sample Collection KitHHT · Traditional | Kolplast CI SA | 01/13/2017SE |
| K141057 | Disposable Cervical BrushHHT · Traditional | Ningbo Hls Medical Products Co., Ltd. | 05/14/2015SE |
| K111681 | HistobrushHHT · Traditional | Puritan Medical Products Company, LLC | 01/19/2012SE |
| K083012 | PapconeHHT · Traditional | Otto Bock Pur Life Science GmbH | 04/09/2009SE |
| K081522 | Bio Nuclear Diagnostics (Endo)Cervical Sampler for Gyn CytologyHHT · Traditional | Bio Nuclear Diagnostics, Inc. | 12/05/2008SE |
| K072381 | Softpap Cervical Cell CollectorHHT · Special | Cytocore, Inc. | 01/30/2008SE |
| K062433 | Diamics Cercol Cervical Sample Collector SystemHHT · Traditional | Diamics, Inc. | 03/16/2007SE |
| K043369 | Cervex-Brush CombiHHT · Traditional | Rovers Medical Devices B.V. | 02/02/2005SE |
| K042527 | Spatula, Cervical, Cytological, Model 22-9107HHT · Traditional | Medical Action Industries, Inc. | 11/08/2004SE |
| K041018 | DRG SoftreleaseHHT · Traditional | Doctor'S Research Group, Inc. | 10/18/2004SE |
| K013258 | Inpath E2 CollectorHHT · Traditional | Molecular Diagnostics | 05/31/2002SE |
| K002520 | Rovers SpatulaHHT · Abbreviated | Rovers Medical Devices B.V. | 11/13/2000SE |
| K001119 | Rovers Endocervex-BrushHHT · Abbreviated | Rovers Medical Devices B.V. | 05/19/2000SE |
| K991595 | Oribrush - with Protective Tip - B001HHT · Traditional | Orifice Medical AB | 06/29/1999SE |
| K991593 | Oribrush - Standard - B002HHT · Traditional | Orifice Medical AB | 06/29/1999SE |
| K983202 | Harwill Medical Cervitula Cervical SpatulaHHT · Traditional | Harwill Medical (Pty) , Ltd. | 03/15/1999SE |
| K983599 | Safetex Chlamydia Trachomatis Specimen Collection KitHHT · Traditional | Andwin Scientific | 12/11/1998SE |
| K983428 | Safetex Cervical Scraper (Plastic)HHT · Traditional | Andwin Scientific | 11/16/1998SE |
| K980356 | Cervical Cytology C-Brush Model CMB-1010HHT · Traditional | Canadian Medical Brush, Inc. | 04/16/1998SE |
| K971586 | Digene Cervical BrushHHT · Traditional | Digene Corp. | 09/19/1997SE |
| K971849 | Cytology BrushHHT · Traditional | Team Technologies, Inc. | 07/24/1997SE |
| K963801 | Pap BrushHHT · Traditional | Young OU Brush Co. | 04/09/1997SE |
| K963685 | Eos Brand Disposable Cyto/Cervical SamplerHHT · Traditional | North Eos Industries, Inc. | 10/11/1996SE |
| K961934 | Puritan Foam Tip Swab Model 2197HHT · Traditional | Hardwood Products Co., LP | 07/09/1996SE |
| K960469 | Detect Cytology Brush IIHHT · Traditional | Cook Urological, Inc. | 03/14/1996SE |
| K954562 | Gynetech P.O.S. Spap Smear Cell Collection & Transport KitHHT · Traditional | Gynetech, Inc. | 12/22/1995SE |
| K950780 | Amsino Cervical ScraperHHT · Traditional | Amsino Intl., Inc. | 07/25/1995SE |
| K941472 | Cervex-Brush Pap KitHHT · Traditional | Rovers Diagnostic Devices | 02/28/1995SESK |
| K933870 | Viba-BrushHHT · Traditional | Rovers B.V. | 01/05/1995SE |
| K934732 | Pelvic Exam TrayHHT · Traditional | Medcare Custom Packaging, Inc. | 12/30/1994SE |
| K942843 | Cervex-Brush(R), Sterile, Spatula, Cervical, CytologyHHT · Traditional | Rovers Diagnostic Devices | 12/08/1994SE |
| K930955 | Cervex-BrushHHT · Traditional | Rovers B.V. | 05/24/1994SE |
| K912325 | Micro-Pap(Tm) KitHHT · Traditional | Micro-Pap Corp. | 05/02/1994SESK |
| K933628 | Cytology BrushHHT · Traditional | Bioteque America, Inc. | 03/11/1994SE |
| K933415 | Detect (TM) Cytology BrushHHT · Traditional | Cook Ob/Gyn | 02/25/1994SE |
| K915844 | Exact-TouchHHT · Traditional | Baal Assoc., Inc. | 01/07/1994SE |
| K911432 | Accellon Cervical BiosamplerHHT · Traditional | Medscand AB | 09/03/1993SE |
| K923143 | Cyto Pak Pap Smear KitHHT · Traditional | International Medical Equipment Brokers, Inc. | 07/16/1993SESK |
| K924908 | Cell Collecting BrushHHT · Traditional | Anderson Winn Paper Co. | 04/13/1993SESK |
| K911327 | Cell SweepHHT · Traditional | Reza S Mohajer, M.D. C/O Krass & Young | 05/21/1991SE |
| K902995 | Pc-Beads Postcoital TestHHT · Traditional | Microscopy Research Innovations | 01/31/1991SE |
| K902591 | Cytette(Tm) Cytology BrushHHT · Traditional | Birchwood Laboratories, Inc. | 09/10/1990SE |
| K902589 | Cytoset(Tm)HHT · Traditional | Birchwood Laboratories, Inc. | 09/10/1990SE |
| K893229 | Spatula for Pap Smear CollectionHHT · Traditional | Medical Device Inspection Co., Inc. | 02/22/1990SE |
| K896065 | Wallach Cc/BrushHHT · Traditional | Wallach Surgical Devices, Inc. | 01/04/1990SE |
| K895675 | Pap Smear TrayHHT · Traditional | Intl. Cytobrush, Inc. | 12/11/1989SE |
| K890848 | Cervex-BrushHHT · Traditional | Unimar, Inc. | 05/11/1989SE |
| K890706 | CytobrushHHT · Traditional | Laboratoire Ccd C/O Washington Regulatory Services | 04/25/1989SE |
| K890013 | Kotex Super Maxi PadsHHT · Traditional | Kimberly-Clark Corp. | 04/25/1989SE |
| K891032 | Endo Cervical Curette - Evans, Randall, GusbergHHT · Traditional | Zinnanti Surgical Instruments, Inc. | 03/22/1989SE |
| K890283 | Cytex One and Cytex TwoHHT · Traditional | Anderson Winn Paper Co. | 03/16/1989SE |
| K885274 | Rocket Endocervical BrushHHT · Traditional | A & A Medical, Inc. | 03/09/1989SE |
| K884873 | Cervical BrushHHT · Traditional | Statlab Medical Products, Inc. | 02/09/1989SE |
| K884042 | Rocket Cervical SpatulaHHT · Traditional | A & A Medical, Inc. | 10/07/1988SE |
| K882628 | Endo C BrushHHT · Traditional | Milex Products, Inc. | 07/25/1988SE |
| K881921 | C-E BrushHHT · Traditional | Surgipath Medical Industries, Inc. | 07/19/1988SE |
| K875162 | Ortho* Specimen Collection Cytology BrushHHT · Traditional | Ortho Diagnostic Systems, Inc. | 01/27/1988SE |
| K874604 | HistobrushHHT · Traditional | Spectrum Co. | 01/07/1988SE |
| K871552 | Ortho* Specimen Collection CytobrushHHT · Traditional | Ortho Diagnostic Systems, Inc. | 06/26/1987SE |
| K870782 | Cyclo-BrushHHT · Traditional | Medline Industries, Inc. | 05/18/1987SE |
| K870398 | Pap-Pak Cytobrush KitHHT · Traditional | Medical Packaging Corp. | 02/25/1987SE |
| K864323 | Cytology BrushesHHT · Traditional | Medical Packaging Corp. | 01/09/1987SE |
| K863145 | Cervical ScrapersHHT · Traditional | Surgipath Medical Industries, Inc. | 08/19/1986SE |
| K862322 | Chlamydia Kit, STD KitHHT · Traditional | Intl. Cytobrush, Inc. | 07/07/1986SE |
| K862242 | Pap Smear KitHHT · Traditional | Quali-Med, Inc. | 06/26/1986SE |
| K861389 | Pap Smear KitHHT · Traditional | Intl. Cytobrush, Inc. | 05/02/1986SE |
| K851934 | Cytological Cervical Spatula the Multi-SpatulaHHT · Traditional | Tridak Division of Indicon, Inc. | 07/05/1985SE |
| K850676 | Surgi-Pap KitHHT · Traditional | Surgipath Medical Industries, Inc. | 03/22/1985SE |
| K832986 | Pap Smear BrushHHT · Traditional | Donald G. Zeller | 02/10/1984SE |
| K811548 | Cervical SpatulaHHT · Traditional | Procedure Products, Inc. | 06/23/1981SE |
| K802139 | Spatula, Cervical Cytological CytologyHHT · Traditional | Dyn-A-Med Products | 10/31/1980SE |
| K761348 | Cervical-Vaginal SpatulaHHT · Traditional | Law Offices of Natter & Natter | 01/18/1977SE |