FDA Product Code HET: Laparoscope, Gynecologic (and Accessories)
Leading manufacturers include KARL STORZ Endoscopy-America, Inc., United States Surgical, A Division of Tyco Healthc and Baxter Healthcare Corp.
338
Total
338
Cleared
205d
Avg days
1977
Since
Growing category -
2 submissions in the last 2 years
vs 1 in the prior period
Review times improving: avg
144d
recently vs 205d historically
FDA 510(k) Cleared Laparoscope, Gynecologic (and Accessories) Devices (Product Code HET)
338 devices
Cleared
Aug 29, 2025
SIRIUS Endoscope System (PR-SI-1230)
Precision Robotics (Hong Kong) Limited
General & Plastic Surgery
154d
Cleared
Apr 25, 2025
i-Cut
A.M.I. Agency For Medical Innovations GmbH
Obstetrics & Gynecology
134d
Cleared
Dec 12, 2022
SIRIUS Endoscope System
Precision Robotics (Hong Kong) Limited
General & Plastic Surgery
189d
Cleared
Oct 13, 2021
Video Endoscopy System, 3D Video Endoscopy System
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Obstetrics & Gynecology
267d
Cleared
Sep 17, 2021
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
Olympus Medical Systems Corp.
Obstetrics & Gynecology
442d
Cleared
Jul 08, 2021
SurroundScope System
270surgical , Ltd.
Obstetrics & Gynecology
175d
Cleared
Mar 12, 2021
TipVision Videoscope System (TipVision VideoScope 0°/30°
Schoelly Fiberoptic GmbH
Obstetrics & Gynecology
270d
Cleared
Aug 21, 2020
4K UHD Camera System
Scivita Medical Technology Co., Ltd.
Obstetrics & Gynecology
206d
Cleared
Apr 03, 2020
LAP-iX Suction Irrigation
Sejong Medical Co., Ltd.
General & Plastic Surgery
24d
Cleared
Nov 01, 2019
WV1 Endoscope
270surgical , Ltd.
Obstetrics & Gynecology
273d
Cleared
Aug 29, 2019
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
Olympus Winter & Ibe GmbH
Obstetrics & Gynecology
160d
Cleared
Jan 18, 2018
Flex Robotic System and Flex Transabdominal Drive
Medrobotics Corporation
Obstetrics & Gynecology
125d
Cleared
Nov 20, 2015
SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology
263d
Cleared
Apr 02, 1999
DCI ENDOSCOPE
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology
88d
Cleared
Sep 10, 1998
SMITH & NEPHEW DYONICS MICROLAPAROSCOPE
Smith & Nephew, Inc.
Obstetrics & Gynecology
84d
Cleared
Aug 19, 1998
KSEA ENDO TIP SYSTEM
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology
142d
Cleared
May 08, 1998
KSEA PLASTIC TROCARS
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology
74d
Cleared
Dec 19, 1997
KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology
505d
Cleared
Dec 02, 1997
MVM 3.3 MM MICROENDOSCOPE
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology
90d
Cleared
Mar 18, 1997
INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
Smith & Nephew, Inc.
Obstetrics & Gynecology
62d
Cleared
Jan 29, 1997
KSEA PUNCTURE CANNULA
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology
86d
Cleared
Dec 20, 1996
KSEA UNIMAT PLUS
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology
79d
Cleared
Dec 19, 1996
KSEA UNIMAT PLUS
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology
78d
Cleared
Sep 30, 1996
KARL STORZ MODEL 203210 O1 UNIMAT PLUS
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology
124d
About Product Code HET - Regulatory Context
510(k) Submission Activity
338 total 510(k) submissions under product code HET since 1977, with 338 receiving FDA clearance (average review time: 205 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - HET Product Code
Recent submissions under HET have taken an average of 144 days to reach a decision - down from 205 days historically, suggesting improved FDA processing for this classification.
HET devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →