HHT · Class II · 21 CFR 884.4530

FDA Product Code HHT: Spatula, Cervical, Cytological

Leading manufacturers include Surgipath Medical Industries, Inc., Ortho Diagnostic Systems, Inc. and Excell Company, LLC.

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 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
Cleared Apr 25, 1989
KOTEX SUPER MAXI PADS
K890013
Kimberly-Clark Corp.
Obstetrics & Gynecology · 112d
Cleared Mar 22, 1989
ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG
K891032
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 22d
Cleared Jul 19, 1988
C-E BRUSH
K881921
Surgipath Medical Industries, Inc.
Obstetrics & Gynecology · 71d
Cleared Jan 27, 1988
ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH
K875162
Ortho Diagnostic Systems, Inc.
Obstetrics & Gynecology · 42d
Cleared Jun 26, 1987
ORTHO* SPECIMEN COLLECTION CYTOBRUSH
K871552
Ortho Diagnostic Systems, Inc.
Obstetrics & Gynecology · 65d
Cleared May 18, 1987
CYCLO-BRUSH
K870782
Medline Industries, Inc.
Obstetrics & Gynecology · 81d
Cleared Aug 19, 1986
CERVICAL SCRAPERS
K863145
Surgipath Medical Industries, Inc.
Obstetrics & Gynecology · 4d
Cleared Mar 22, 1985
SURGI-PAP KIT
K850676
Surgipath Medical Industries, Inc.
Obstetrics & Gynecology · 29d

About Product Code HHT - Regulatory Context