FDA Product Code
FDA Product Code HHT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4530
510(k) Clearances — 73 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K182049 | exCellerator Cervical Collection Device | Excell Company, LLC | 2019-04-25 | Traditional | PDF ↗ |
| K153128 | Kolplast Cervical Sample Collection Kit | Kolplast CI SA | 2017-01-13 | Traditional | PDF ↗ |
| K141057 | DISPOSABLE CERVICAL BRUSH | Ningbo Hls Medical Products Co., Ltd. | 2015-05-14 | Traditional | PDF ↗ |
| K111681 | HISTOBRUSH | Puritan Medical Products Company, LLC | 2012-01-19 | Traditional | PDF ↗ |
| K083012 | PAPCONE | Otto Bock Pur Life Science GmbH | 2009-04-09 | Traditional | PDF ↗ |
| K081522 | BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY | Bio Nuclear Diagnostics, Inc. | 2008-12-05 | Traditional | PDF ↗ |
| K072381 | SOFTPAP CERVICAL CELL COLLECTOR | Cytocore, Inc. | 2008-01-30 | Special | PDF ↗ |
| K062433 | DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM | Diamics, Inc. | 2007-03-16 | Traditional | PDF ↗ |
| K043369 | CERVEX-BRUSH COMBI | Rovers Medical Devices B.V. | 2005-02-02 | Traditional | PDF ↗ |
| K042527 | SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 | Medical Action Industries, Inc. | 2004-11-08 | Traditional | PDF ↗ |
| K041018 | DRG SOFTRELEASE | Doctor'S Research Group, Inc. | 2004-10-18 | Traditional | PDF ↗ |
| K013258 | INPATH E2 COLLECTOR | Molecular Diagnostics | 2002-05-31 | Traditional | PDF ↗ |
| K002520 | ROVERS SPATULA | Rovers Medical Devices B.V. | 2000-11-13 | Abbreviated | PDF ↗ |
| K001119 | ROVERS ENDOCERVEX-BRUSH | Rovers Medical Devices B.V. | 2000-05-19 | Abbreviated | PDF ↗ |
| K991595 | ORIBRUSH - WITH PROTECTIVE TIP - B001 | Orifice Medical AB | 1999-06-29 | Traditional | PDF ↗ |
| K991593 | ORIBRUSH - STANDARD - B002 | Orifice Medical AB | 1999-06-29 | Traditional | PDF ↗ |
| K983202 | HARWILL MEDICAL CERVITULA CERVICAL SPATULA | Harwill Medical (Pty) , Ltd. | 1999-03-15 | Traditional | PDF ↗ |
| K983599 | SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT | Andwin Scientific | 1998-12-11 | Traditional | PDF ↗ |
| K983428 | SAFETEX CERVICAL SCRAPER (PLASTIC) | Andwin Scientific | 1998-11-16 | Traditional | PDF ↗ |
| K980356 | CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010 | Canadian Medical Brush, Inc. | 1998-04-16 | Traditional | PDF ↗ |
| K971586 | DIGENE CERVICAL BRUSH | Digene Corp. | 1997-09-19 | Traditional | PDF ↗ |
| K971849 | CYTOLOGY BRUSH | Team Technologies, Inc. | 1997-07-24 | Traditional | PDF ↗ |
| K963801 | PAP BRUSH | Young OU Brush Co. | 1997-04-09 | Traditional | PDF ↗ |
| K963685 | EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER | North Eos Industries, Inc. | 1996-10-11 | Traditional | PDF ↗ |
| K961934 | PURITAN FOAM TIP SWAB MODEL 2197 | Hardwood Products Co., LP | 1996-07-09 | Traditional | PDF ↗ |
| K960469 | DETECT CYTOLOGY BRUSH II | Cook Urological, Inc. | 1996-03-14 | Traditional | PDF ↗ |
| K954562 | GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT | Gynetech, Inc. | 1995-12-22 | Traditional | PDF ↗ |
| K950780 | AMSINO CERVICAL SCRAPER | Amsino Intl., Inc. | 1995-07-25 | Traditional | PDF ↗ |
| K941472 | CERVEX-BRUSH PAP KIT | Rovers Diagnostic Devices | 1995-02-28 | Traditional | PDF ↗ |
| K933870 | VIBA-BRUSH | Rovers B.V. | 1995-01-05 | Traditional | PDF ↗ |
| K934732 | PELVIC EXAM TRAY | Medcare Custom Packaging, Inc. | 1994-12-30 | Traditional | PDF ↗ |
| K942843 | CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY | Rovers Diagnostic Devices | 1994-12-08 | Traditional | PDF ↗ |
| K930955 | CERVEX-BRUSH | Rovers B.V. | 1994-05-24 | Traditional | PDF ↗ |
| K912325 | MICRO-PAP(TM) KIT | Micro-Pap Corp. | 1994-05-02 | Traditional | PDF ↗ |
| K933628 | CYTOLOGY BRUSH | Bioteque America, Inc. | 1994-03-11 | Traditional | PDF ↗ |
| K933415 | DETECT (TM) CYTOLOGY BRUSH | Cook Ob/Gyn | 1994-02-25 | Traditional | PDF ↗ |
| K915844 | EXACT-TOUCH | Baal Assoc., Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K911432 | ACCELLON CERVICAL BIOSAMPLER | Medscand AB | 1993-09-03 | Traditional | PDF ↗ |
| K923143 | CYTO PAK PAP SMEAR KIT | International Medical Equipment Brokers, Inc. | 1993-07-16 | Traditional | PDF ↗ |
| K924908 | CELL COLLECTING BRUSH | Anderson Winn Paper Co. | 1993-04-13 | Traditional | PDF ↗ |
| K911327 | CELL SWEEP | Reza S Mohajer, M.D. C/O Krass & Young | 1991-05-21 | Traditional | PDF ↗ |
| K902995 | PC-BEADS POSTCOITAL TEST | Microscopy Research Innovations | 1991-01-31 | Traditional | PDF ↗ |
| K902591 | CYTETTE(TM) CYTOLOGY BRUSH | Birchwood Laboratories, Inc. | 1990-09-10 | Traditional | PDF ↗ |
| K902589 | CYTOSET(TM) | Birchwood Laboratories, Inc. | 1990-09-10 | Traditional | PDF ↗ |
| K893229 | SPATULA FOR PAP SMEAR COLLECTION | Medical Device Inspection Co., Inc. | 1990-02-22 | Traditional | PDF ↗ |
| K896065 | WALLACH CC/BRUSH | Wallach Surgical Devices, Inc. | 1990-01-04 | Traditional | PDF ↗ |
| K895675 | PAP SMEAR TRAY | Intl. Cytobrush, Inc. | 1989-12-11 | Traditional | PDF ↗ |
| K890848 | CERVEX-BRUSH | Unimar, Inc. | 1989-05-11 | Traditional | PDF ↗ |
| K890013 | KOTEX SUPER MAXI PADS | Kimberly-Clark Corp. | 1989-04-25 | Traditional | PDF ↗ |
| K890706 | CYTOBRUSH | Laboratoire Ccd C/O Washington Regulatory Services | 1989-04-25 | Traditional | PDF ↗ |
| K891032 | ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG | Zinnanti Surgical Instruments, Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K890283 | CYTEX ONE AND CYTEX TWO | Anderson Winn Paper Co. | 1989-03-16 | Traditional | PDF ↗ |
| K885274 | ROCKET ENDOCERVICAL BRUSH | A & A Medical, Inc. | 1989-03-09 | Traditional | PDF ↗ |
| K884873 | CERVICAL BRUSH | Statlab Medical Products, Inc. | 1989-02-09 | Traditional | PDF ↗ |
| K884042 | ROCKET CERVICAL SPATULA | A & A Medical, Inc. | 1988-10-07 | Traditional | PDF ↗ |
| K882628 | ENDO C BRUSH | Milex Products, Inc. | 1988-07-25 | Traditional | PDF ↗ |
| K881921 | C-E BRUSH | Surgipath Medical Industries, Inc. | 1988-07-19 | Traditional | PDF ↗ |
| K875162 | ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH | Ortho Diagnostic Systems, Inc. | 1988-01-27 | Traditional | PDF ↗ |
| K874604 | HISTOBRUSH | Spectrum Co. | 1988-01-07 | Traditional | PDF ↗ |
| K871552 | ORTHO* SPECIMEN COLLECTION CYTOBRUSH | Ortho Diagnostic Systems, Inc. | 1987-06-26 | Traditional | PDF ↗ |
| K870782 | CYCLO-BRUSH | Medline Industries, Inc. | 1987-05-18 | Traditional | PDF ↗ |
| K870398 | PAP-PAK CYTOBRUSH KIT | Medical Packaging Corp. | 1987-02-25 | Traditional | PDF ↗ |
| K864323 | CYTOLOGY BRUSHES | Medical Packaging Corp. | 1987-01-09 | Traditional | PDF ↗ |
| K863145 | CERVICAL SCRAPERS | Surgipath Medical Industries, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K862322 | CHLAMYDIA KIT, STD KIT | Intl. Cytobrush, Inc. | 1986-07-07 | Traditional | PDF ↗ |
| K862242 | PAP SMEAR KIT | Quali-Med, Inc. | 1986-06-26 | Traditional | PDF ↗ |
| K861389 | PAP SMEAR KIT | Intl. Cytobrush, Inc. | 1986-05-02 | Traditional | PDF ↗ |
| K851934 | CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA | Tridak Division of Indicon, Inc. | 1985-07-05 | Traditional | PDF ↗ |
| K850676 | SURGI-PAP KIT | Surgipath Medical Industries, Inc. | 1985-03-22 | Traditional | PDF ↗ |
| K832986 | PAP SMEAR BRUSH | Donald G. Zeller | 1984-02-10 | Traditional | PDF ↗ |
| K811548 | CERVICAL SPATULA | Procedure Products, Inc. | 1981-06-23 | Traditional | PDF ↗ |
| K802139 | SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY | Dyn-A-Med Products | 1980-10-31 | Traditional | PDF ↗ |
| K761348 | CERVICAL-VAGINAL SPATULA | Law Offices of Natter & Natter | 1977-01-18 | Traditional | PDF ↗ |
Product code HHT · Class II · Obstetrics/Gynecology. Data: openFDA.