HIG · Class II · 21 CFR 884.1700

FDA Product Code HIG: Insufflator, Hysteroscopic

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., W.O.M. World of Medicine GmbH and Karl Storz SE & CO. KG.

56
Total
56
Cleared
249d
Avg days
1984
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 226d avg (recent)

FDA 510(k) Cleared Insufflator, Hysteroscopic Devices (Product Code HIG)

56 devices
1–24 of 56
Cleared Mar 27, 2026
Asurys Fluid Management System
K251273
Boston Scientific Corporation
Obstetrics & Gynecology · 337d
Cleared Jul 25, 2024
Fluent Pro Fluid Management System (FLT-200)
K240886
Hologic, Inc.
Obstetrics & Gynecology · 115d
Cleared Nov 04, 2021
X-FLO Fluid Management System
K210628
Thermedx, LLC
Obstetrics & Gynecology · 247d
Cleared Jul 22, 2020
Endomat Select, IBS Shaver Software, License
K201355
Karl Storz SE & CO. KG
Obstetrics & Gynecology · 62d
Cleared Oct 31, 2018
Endomat Select
K180735
Karl Storz SE & CO. KG
Obstetrics & Gynecology · 223d
Cleared Aug 03, 2018
Fluent Fluid Management System
K180825
Hologic, Inc.
Obstetrics & Gynecology · 126d
Cleared Mar 28, 2018
GYN-Pump PH304
K173489
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 135d
Cleared Feb 05, 2018
Aquilex Fluid Control System AQL-100S
K172040
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 215d
Cleared Nov 30, 2000
KARL STORZ HYSTEROMAT II
K000806
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 262d
Cleared Oct 03, 1996
KARL STORZ MODEL 203020 20 EQUIMAT
K961091
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 198d
Cleared May 25, 1995
KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP
K950961
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 84d
Cleared Dec 18, 1991
THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR
K912498
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 196d
Cleared Oct 10, 1990
DAVOL SCOPE IRRIGATION SYSTEM
K901288
C.R. Bard, Inc.
Obstetrics & Gynecology · 204d
Cleared May 21, 1990
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
K900908
Zimmer, Inc.
Obstetrics & Gynecology · 83d
Cleared Nov 16, 1987
INSUFFLATOR TUBING
K872860
Medline Industries, Inc.
Obstetrics & Gynecology · 118d

About Product Code HIG - Regulatory Context

510(k) Submission Activity

56 total 510(k) submissions under product code HIG since 1984, with 56 receiving FDA clearance (average review time: 249 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - HIG Product Code

FDA review times for HIG submissions have been consistent, averaging 226 days recently vs 250 days historically.

HIG devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →