HIHClass II

Hysteroscope (And Accessories)

21 CFR 884.1690 / Obstetrics/Gynecology

HIH is the FDA product code for Hysteroscope (And Accessories), a class II device type, regulated under 21 CFR 884.1690. As of 2026-09-10, FDA records hold 172 510(k) clearances under this code, the most recent dated 2026-08-18, and 14 recalls.

Classification record

Product code: HIH
Device name: Hysteroscope (And Accessories)
Regulation: 21 CFR 884.1690
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: 175
Ingested recalls: 16

Clearances, product code HIH

By decision year

175 clearances under product code HIH with a decision year between 1980 and 2026, 2019 the highest year at 14.

Show the numbers

510(k) clearances under FDA product code HIH by decision year
Year	Clearances
1980	1
1981	3
1984	1
1988	3
1989	2
1990	6
1991	1
1992	1
1994	7
1995	12
1996	9
1997	8
1998	6
1999	9
2000	4
2001	1
2002	3
2003	4
2004	3
2006	1
2007	1
2008	2
2009	4
2010	4
2011	3
2012	4
2013	5
2014	2
2015	5
2016	3
2017	2
2018	8
2019	14
2020	7
2021	4
2022	2
2023	4
2024	6
2025	3
2026	7

Applicants with the most clearances

Product code HIH

Applicants holding the most 510(k) clearances under product code HIH
Applicant	Clearances
Karl Storz Endoscopy-America, Inc.	14
Hologic, Inc.	13
Smith & Nephew, Inc.	10
Interlace Medical, Inc.	6
Richard Wolf Medical Instruments Corp.	6
CooperSurgical, Inc.	5
Imagyn Medical, Inc.	5
Meditrina, Inc.	5
Boston Scientific Corporation	4
Olympus Corp.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 115 companies shown, in name order