HHT · Class II · 21 CFR 884.4530

FDA Product Code HHT: Spatula, Cervical, Cytological

Leading manufacturers include Surgipath Medical Industries, Inc., Andwin Scientific and Ortho Diagnostic Systems, Inc..

73
Total
73
Cleared
163d
Avg days
1977
Since

FDA 510(k) Cleared Spatula, Cervical, Cytological Devices (Product Code HHT)

73 devices
1–24 of 73
Cleared Apr 25, 2019
exCellerator Cervical Collection Device
K182049
Excell Company, LLC
Pathology · 268d
Cleared Jan 13, 2017
Kolplast Cervical Sample Collection Kit
K153128
Kolplast CI SA
Pathology · 442d
Cleared May 14, 2015
DISPOSABLE CERVICAL BRUSH
K141057
Ningbo Hls Medical Products Co., Ltd.
Obstetrics & Gynecology · 385d
Cleared Jan 19, 2012
HISTOBRUSH
K111681
Puritan Medical Products Company, LLC
Obstetrics & Gynecology · 218d
Cleared Apr 09, 2009
PAPCONE
K083012
Otto Bock Pur Life Science GmbH
Obstetrics & Gynecology · 182d
Cleared Dec 05, 2008
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
K081522
Bio Nuclear Diagnostics, Inc.
Obstetrics & Gynecology · 189d
Cleared Jan 30, 2008
SOFTPAP CERVICAL CELL COLLECTOR
K072381
Cytocore, Inc.
Obstetrics & Gynecology · 159d
Cleared Mar 16, 2007
DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
K062433
Diamics, Inc.
Obstetrics & Gynecology · 207d
Cleared Feb 02, 2005
CERVEX-BRUSH COMBI
K043369
Rovers Medical Devices B.V.
Obstetrics & Gynecology · 56d
Cleared Nov 08, 2004
SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
K042527
Medical Action Industries, Inc.
Obstetrics & Gynecology · 52d
Cleared Jun 29, 1999
ORIBRUSH - STANDARD - B002
K991593
Orifice Medical AB
Obstetrics & Gynecology · 53d
Cleared Jun 29, 1999
ORIBRUSH - WITH PROTECTIVE TIP - B001
K991595
Orifice Medical AB
Obstetrics & Gynecology · 53d
Cleared Mar 15, 1999
HARWILL MEDICAL CERVITULA CERVICAL SPATULA
K983202
Harwill Medical (Pty) , Ltd.
Obstetrics & Gynecology · 182d
Cleared Dec 11, 1998
SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
K983599
Andwin Scientific
Microbiology · 58d
Cleared Nov 16, 1998
SAFETEX CERVICAL SCRAPER (PLASTIC)
K983428
Andwin Scientific
Obstetrics & Gynecology · 48d
Cleared Apr 16, 1998
CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010
K980356
Canadian Medical Brush, Inc.
Obstetrics & Gynecology · 77d
Cleared Sep 19, 1997
DIGENE CERVICAL BRUSH
K971586
Digene Corp.
Obstetrics & Gynecology · 141d
Cleared Jul 24, 1997
CYTOLOGY BRUSH
K971849
Team Technologies, Inc.
Obstetrics & Gynecology · 66d
Cleared Apr 09, 1997
PAP BRUSH
K963801
Young OU Brush Co.
Obstetrics & Gynecology · 198d
Cleared Oct 11, 1996
EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER
K963685
North Eos Industries, Inc.
Obstetrics & Gynecology · 38d
Cleared Jul 09, 1996
PURITAN FOAM TIP SWAB MODEL 2197
K961934
Hardwood Products Co., LP
Obstetrics & Gynecology · 53d
Cleared Mar 14, 1996
DETECT CYTOLOGY BRUSH II
K960469
Cook Urological, Inc.
Obstetrics & Gynecology · 42d
Cleared Feb 25, 1994
DETECT (TM) CYTOLOGY BRUSH
K933415
Cook Ob/Gyn
Obstetrics & Gynecology · 227d
Cleared Feb 22, 1990
SPATULA FOR PAP SMEAR COLLECTION
K893229
Medical Device Inspection Co., Inc.
Obstetrics & Gynecology · 300d

About Product Code HHT - Regulatory Context