Product Code: HHT FDA class 2 21 CFR 884.4530

Spatula, Cervical, Cytological

Obstetrics/Gynecology

The Cytological Cervical Spatula is a sampling instrument used to scrape cells from the transformation zone of the cervix for cytological examination, most commonly as part of a Pap smear screening procedure for cervical cancer or precancerous conditions. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HHT, regulated under 21 CFR 884.4530, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

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Basic Information

Product Code: HHT
Device Class: FDA class 2
Regulation Number: 884.4530
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 73 510(k) clearances via K numbers.

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