Product code HHT— Obstetrics/Gynecology
CERVEX-BRUSH
- Classification name
- Spatula, Cervical, Cytological
- Device class
- Class 2
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 73
- First cleared
- Most recent
Market context for product code HHT
FDA has cleared devices under product code HHT between 1977 and 2019, filed by 58 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2019
- 2017
- 2015
- 2012
- 2009
- 2008
- 2007
- 2005
- 2004
- 2002
- 2000
- 1999
- 1998
- 1997
- 1996
Top applicants under product code HHT
Recent clearances under product code HHT
- K182049 — exCellerator Cervical Collection Device
- K153128 — Kolplast Cervical Sample Collection Kit
- K141057 — DISPOSABLE CERVICAL BRUSH
- K111681 — HISTOBRUSH
- K083012 — PAPCONE
- K081522 — BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
- K072381 — SOFTPAP CERVICAL CELL COLLECTOR
- K062433 — DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
- K043369 — CERVEX-BRUSH COMBI
- K042527 — SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
- K041018 — DRG SOFTRELEASE
- K013258 — INPATH E2 COLLECTOR
- K002520 — ROVERS SPATULA
- K001119 — ROVERS ENDOCERVEX-BRUSH
- K991593 — ORIBRUSH - STANDARD - B002
- K991595 — ORIBRUSH - WITH PROTECTIVE TIP - B001
- K983202 — HARWILL MEDICAL CERVITULA CERVICAL SPATULA
- K983599 — SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
- K983428 — SAFETEX CERVICAL SCRAPER (PLASTIC)
- K980356 — CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010
- K971586 — DIGENE CERVICAL BRUSH
- K971849 — CYTOLOGY BRUSH
- K963801 — PAP BRUSH
- K963685 — EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER
- K961934 — PURITAN FOAM TIP SWAB MODEL 2197
- K960469 — DETECT CYTOLOGY BRUSH II
- K954562 — GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT
- K950780 — AMSINO CERVICAL SCRAPER
- K941472 — CERVEX-BRUSH PAP KIT
- K933870 — VIBA-BRUSH
- K934732 — PELVIC EXAM TRAY
- K942843 — CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY
- K930955 — CERVEX-BRUSH
- K912325 — MICRO-PAP(TM) KIT
- K933628 — CYTOLOGY BRUSH
- K933415 — DETECT (TM) CYTOLOGY BRUSH
- K915844 — EXACT-TOUCH
- K911432 — ACCELLON CERVICAL BIOSAMPLER
- K923143 — CYTO PAK PAP SMEAR KIT
- K924908 — CELL COLLECTING BRUSH
- K911327 — CELL SWEEP
- K902995 — PC-BEADS POSTCOITAL TEST
- K902589 — CYTOSET(TM)
- K902591 — CYTETTE(TM) CYTOLOGY BRUSH
- K893229 — SPATULA FOR PAP SMEAR COLLECTION
- K896065 — WALLACH CC/BRUSH
- K895675 — PAP SMEAR TRAY
- K890848 — CERVEX-BRUSH
- K890013 — KOTEX SUPER MAXI PADS
- K890706 — CYTOBRUSH
- K891032 — ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG
- K890283 — CYTEX ONE AND CYTEX TWO
- K885274 — ROCKET ENDOCERVICAL BRUSH
- K884873 — CERVICAL BRUSH
- K884042 — ROCKET CERVICAL SPATULA
- K882628 — ENDO C BRUSH
- K881921 — C-E BRUSH
- K875162 — ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH
- K874604 — HISTOBRUSH
- K871552 — ORTHO* SPECIMEN COLLECTION CYTOBRUSH
- K870782 — CYCLO-BRUSH
- K870398 — PAP-PAK CYTOBRUSH KIT
- K864323 — CYTOLOGY BRUSHES
- K863145 — CERVICAL SCRAPERS
- K862322 — CHLAMYDIA KIT, STD KIT
- K862242 — PAP SMEAR KIT
- K861389 — PAP SMEAR KIT
- K851934 — CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA
- K850676 — SURGI-PAP KIT
- K832986 — PAP SMEAR BRUSH
- K811548 — CERVICAL SPATULA
- K802139 — SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY
- K761348 — CERVICAL-VAGINAL SPATULA
Data sourced from openFDA. This site is unofficial and independent of the FDA.