FDA 510(k) Applications for Medical Device Product Code "HHT"
(Spatula, Cervical, Cytological)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K983428 | ANDWIN SCIENTIFIC | SAFETEX CERVICAL SCRAPER (PLASTIC) | 11/16/1998 |
| K983599 | ANDWIN SCIENTIFIC | SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT | 12/11/1998 |
| K081522 | BIO NUCLEAR DIAGNOSTICS, INC. | BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY | 12/05/2008 |
| K980356 | CANADIAN MEDICAL BRUSH, INC. | CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010 | 04/16/1998 |
| K960469 | COOK UROLOGICAL, INC. | DETECT CYTOLOGY BRUSH II | 03/14/1996 |
| K072381 | CYTOCORE, INC. | SOFTPAP CERVICAL CELL COLLECTOR | 01/30/2008 |
| K062433 | DIAMICS, INC. | DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM | 03/16/2007 |
| K971586 | DIGENE CORP. | DIGENE CERVICAL BRUSH | 09/19/1997 |
| K041018 | DOCTOR'S RESEARCH GROUP, INC. | DRG SOFTRELEASE | 10/18/2004 |
| K182049 | ExCell Company LLC | exCellerator Cervical Collection Device | 04/25/2019 |
| K961934 | HARDWOOD PRODUCTS CO., LP | PURITAN FOAM TIP SWAB MODEL 2197 | 07/09/1996 |
| K983202 | HARWILL MEDICAL (PTY) LTD. | HARWILL MEDICAL CERVITULA CERVICAL SPATULA | 03/15/1999 |
| K153128 | KOLPLAST CI SA | Kolplast Cervical Sample Collection Kit | 01/13/2017 |
| K042527 | MEDICAL ACTION INDUSTRIES, INC. | SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 | 11/08/2004 |
| K013258 | MOLECULAR DIAGNOSTICS | INPATH E2 COLLECTOR | 05/31/2002 |
| K141057 | NINGBO HLS MEDICAL PRODUCTS CO., LTD | DISPOSABLE CERVICAL BRUSH | 05/14/2015 |
| K963685 | NORTH EOS INDUSTRIES, INC. | EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER | 10/11/1996 |
| K991593 | ORIFICE MEDICAL AB | ORIBRUSH - STANDARD - B002 | 06/29/1999 |
| K991595 | ORIFICE MEDICAL AB | ORIBRUSH - WITH PROTECTIVE TIP - B001 | 06/29/1999 |
| K083012 | OTTO BOCK PUR LIFE SCIENCE GMBH | PAPCONE | 04/09/2009 |
| K111681 | PURITAN MEDICAL PRODUCTS COMPANY LLC | HISTOBRUSH | 01/19/2012 |
| K043369 | ROVERS MEDICAL DEVICES B.V. | CERVEX-BRUSH COMBI | 02/02/2005 |
| K001119 | ROVERS MEDICAL DEVICES B.V. | ROVERS ENDOCERVEX-BRUSH | 05/19/2000 |
| K002520 | ROVERS MEDICAL DEVICES B.V. | ROVERS SPATULA | 11/13/2000 |
| K971849 | TEAM TECHNOLOGIES, INC. | CYTOLOGY BRUSH | 07/24/1997 |
| K963801 | YOUNG OU BRUSH CO. | PAP BRUSH | 04/09/1997 |
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