HHTClass II

Spatula, Cervical, Cytological

21 CFR 884.4530 / Obstetrics/Gynecology

HHT is the FDA product code for Spatula, Cervical, Cytological, a class II device type, regulated under 21 CFR 884.4530. As of 2026-09-10, FDA records hold 73 510(k) clearances under this code, the most recent dated 2019-04-25, and no recalls.

Classification record

Product code: HHT
Device name: Spatula, Cervical, Cytological
Regulation: 21 CFR 884.4530
Device class: Class II
Review panel: Obstetrics/Gynecology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 73
Ingested recalls: 0

Clearances, product code HHT

By decision year

73 clearances under product code HHT with a decision year between 1977 and 2019, 1989 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code HHT by decision year
Year	Clearances
1977	1
1980	1
1981	1
1984	1
1985	2
1986	4
1987	4
1988	5
1989	8
1990	4
1991	2
1993	3
1994	7
1995	4
1996	3
1997	3
1998	3
1999	3
2000	2
2002	1
2004	2
2005	1
2007	1
2008	2
2009	1
2012	1
2015	1
2017	1
2019	1

Applicants with the most clearances

Product code HHT

Applicants holding the most 510(k) clearances under product code HHT
Applicant	Clearances
Intl. Cytobrush, Inc.	3
Rovers Medical Devices B.V.	3
Surgipath Medical Industries, Inc.	3
A & A Medical, Inc.	2
Anderson Winn Paper Co.	2
Andwin Scientific	2
Birchwood Laboratories LLC	2
Medical Packaging Corporation	2
Orifice Medical AB	2
Ortho Diagnostic Systems, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order