HETClass II

Laparoscope, Gynecologic (And Accessories)

21 CFR 884.1720 / Obstetrics/Gynecology

HET is the FDA product code for Laparoscope, Gynecologic (And Accessories), a class II device type, regulated under 21 CFR 884.1720. As of 2026-09-10, FDA records hold 338 510(k) clearances under this code, the most recent dated 2025-08-29, and 19 recalls.

Classification record

Product code: HET
Device name: Laparoscope, Gynecologic (And Accessories)
Regulation: 21 CFR 884.1720
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: No
Ingested clearances: 338
Ingested recalls: 19

Clearances, product code HET

By decision year

338 clearances under product code HET with a decision year between 1977 and 2025, 1994 the highest year at 61.

Show the numbers

510(k) clearances under FDA product code HET by decision year
Year	Clearances
1977	11
1979	1
1980	1
1981	3
1983	5
1984	1
1985	3
1986	1
1988	7
1989	2
1990	37
1991	18
1992	18
1993	11
1994	61
1995	50
1996	20
1997	21
1998	10
1999	7
2000	6
2001	4
2002	3
2003	1
2004	3
2005	2
2006	4
2008	3
2009	1
2010	1
2011	2
2012	2
2013	2
2015	2
2017	2
2018	1
2019	2
2020	2
2021	4
2022	1
2025	2

Applicants with the most clearances

Product code HET

Applicants holding the most 510(k) clearances under product code HET
Applicant	Clearances
Karl Storz Endoscopy-America, Inc.	30
Dixon Medical, Inc.	12
Ethicon, Inc	11
Marlo Surgical Technology	10
Baxter Healthcare Corporation	9
Richard Wolf Medical Instruments Corp.	9
United States Surgical, A Division of Tyco Healthc	9
OLYMPUS Corporation of the Americas	8
Paladin Medical, Inc.	8
Applied Medical Resources Corp	7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 124 companies shown, in name order