HHT
73 FDA 510(k) clearances · Product code
80 daysmedian time to decision
385 days90th percentile
73clearances measured
FDA profile
- Official device name
- Spatula, Cervical, Cytological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1996: 1 · 2003: 1 · 2005: 2 · 2007: 2 · 2008: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| HISTOBRUSH (K111681) | Puritan Medical Products Company, LLC | 2012-01-19 |
| 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 |
| ROVERS ENDOCERVEX-BRUSH (K001119) | Rovers Medical Devices B.V. | 2000-05-19 |
| ORIBRUSH - WITH PROTECTIVE TIP - B001 (K991595) | Orifice Medical AB | 1999-06-29 |
| ORIBRUSH - STANDARD - B002 (K991593) | Orifice Medical AB | 1999-06-29 |
| HARWILL MEDICAL CERVITULA CERVICAL SPATULA (K983202) | Harwill Medical (Pty) , Ltd. | 1999-03-15 |
| SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT (K983599) | Andwin Scientific | 1998-12-11 |
| SAFETEX CERVICAL SCRAPER (PLASTIC) (K983428) | Andwin Scientific | 1998-11-16 |
| CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010 (K980356) | Canadian Medical Brush, Inc. | 1998-04-16 |
| DIGENE CERVICAL BRUSH (K971586) | Digene Corp. | 1997-09-19 |
| CYTOLOGY BRUSH (K971849) | Team Technologies, Inc. | 1997-07-24 |
| PAP BRUSH (K963801) | Young OU Brush Co. | 1997-04-09 |
| EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER (K963685) | North Eos Industries, Inc. | 1996-10-11 |
| PURITAN FOAM TIP SWAB MODEL 2197 (K961934) | Hardwood Products Co., LP | 1996-07-09 |
| DETECT CYTOLOGY BRUSH II (K960469) | Cook Urological, Inc. | 1996-03-14 |
| GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT (K954562) | Gynetech, Inc. | 1995-12-22 |
| AMSINO CERVICAL SCRAPER (K950780) | Amsino Intl., Inc. | 1995-07-25 |
| CERVEX-BRUSH PAP KIT (K941472) | Rovers Diagnostic Devices | 1995-02-28 |
| VIBA-BRUSH (K933870) | Rovers B.V. | 1995-01-05 |
| PELVIC EXAM TRAY (K934732) | Medcare Custom Packaging, Inc. | 1994-12-30 |
| CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY (K942843) | Rovers Diagnostic Devices | 1994-12-08 |
| CERVEX-BRUSH (K930955) | Rovers B.V. | 1994-05-24 |
| MICRO-PAP(TM) KIT (K912325) | Micro-Pap Corp. | 1994-05-02 |
| CYTOLOGY BRUSH (K933628) | Bioteque America, Inc. | 1994-03-11 |
| DETECT (TM) CYTOLOGY BRUSH (K933415) | Cook Ob/Gyn | 1994-02-25 |
| EXACT-TOUCH (K915844) | Baal Assoc., Inc. | 1994-01-07 |
| ACCELLON CERVICAL BIOSAMPLER (K911432) | Medscand AB | 1993-09-03 |
| CYTO PAK PAP SMEAR KIT (K923143) | International Medical Equipment Brokers, Inc. | 1993-07-16 |
| CELL COLLECTING BRUSH (K924908) | Anderson Winn Paper Co. | 1993-04-13 |
| CELL SWEEP (K911327) | Reza S Mohajer, M.D. C/O Krass & Young | 1991-05-21 |
| PC-BEADS POSTCOITAL TEST (K902995) | Microscopy Research Innovations | 1991-01-31 |
| CYTETTE(TM) CYTOLOGY BRUSH (K902591) | Birchwood Laboratories, Inc. | 1990-09-10 |
| CYTOSET(TM) (K902589) | Birchwood Laboratories, Inc. | 1990-09-10 |
| SPATULA FOR PAP SMEAR COLLECTION (K893229) | Medical Device Inspection Co., Inc. | 1990-02-22 |
| WALLACH CC/BRUSH (K896065) | Wallach Surgical Devices, Inc. | 1990-01-04 |
| PAP SMEAR TRAY (K895675) | Intl. Cytobrush, Inc. | 1989-12-11 |
| CERVEX-BRUSH (K890848) | Unimar, Inc. | 1989-05-11 |
| CYTOBRUSH (K890706) | Laboratoire Ccd C/O Washington Regulatory Services | 1989-04-25 |
| KOTEX SUPER MAXI PADS (K890013) | Kimberly-Clark Corp. | 1989-04-25 |
| ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG (K891032) | Zinnanti Surgical Instruments, Inc. | 1989-03-22 |
| CYTEX ONE AND CYTEX TWO (K890283) | Anderson Winn Paper Co. | 1989-03-16 |
| ROCKET ENDOCERVICAL BRUSH (K885274) | A & A Medical, Inc. | 1989-03-09 |
| CERVICAL BRUSH (K884873) | Statlab Medical Products, Inc. | 1989-02-09 |
| ROCKET CERVICAL SPATULA (K884042) | A & A Medical, Inc. | 1988-10-07 |
| ENDO C BRUSH (K882628) | Milex Products, Inc. | 1988-07-25 |
| C-E BRUSH (K881921) | Surgipath Medical Industries, Inc. | 1988-07-19 |
| ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH (K875162) | Ortho Diagnostic Systems, Inc. | 1988-01-27 |
| HISTOBRUSH (K874604) | Spectrum Co. | 1988-01-07 |
| ORTHO* SPECIMEN COLLECTION CYTOBRUSH (K871552) | Ortho Diagnostic Systems, Inc. | 1987-06-26 |
| CYCLO-BRUSH (K870782) | Medline Industries, Inc. | 1987-05-18 |
| PAP-PAK CYTOBRUSH KIT (K870398) | Medical Packaging Corp. | 1987-02-25 |
| CYTOLOGY BRUSHES (K864323) | Medical Packaging Corp. | 1987-01-09 |
| CERVICAL SCRAPERS (K863145) | Surgipath Medical Industries, Inc. | 1986-08-19 |
| CHLAMYDIA KIT, STD KIT (K862322) | Intl. Cytobrush, Inc. | 1986-07-07 |
| PAP SMEAR KIT (K862242) | Quali-Med, Inc. | 1986-06-26 |
| PAP SMEAR KIT (K861389) | Intl. Cytobrush, Inc. | 1986-05-02 |
| CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA (K851934) | Tridak Division of Indicon, Inc. | 1985-07-05 |
| SURGI-PAP KIT (K850676) | Surgipath Medical Industries, Inc. | 1985-03-22 |
| PAP SMEAR BRUSH (K832986) | Donald G. Zeller | 1984-02-10 |
| CERVICAL SPATULA (K811548) | Procedure Products, Inc. | 1981-06-23 |
| SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY (K802139) | Dyn-A-Med Products | 1980-10-31 |
| CERVICAL-VAGINAL SPATULA (K761348) | Law Offices of Natter & Natter | 1977-01-18 |
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Every clearance here is in the API, with alerts when new ones post.