HIG · Class II · 21 CFR 884.1700

FDA Product Code HIG: Insufflator, Hysteroscopic

Leading manufacturers include W.O.M. World of Medicine GmbH, Davol Inc., Sub. C. R. Bard, Inc. and W.O.M. World of Medicine AG.

57
Total
57
Cleared
245d
Avg days
1984
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times improving: avg 196d recently vs 247d historically

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

57 devices
1–24 of 57
Cleared Jul 16, 2026
Endomat Select (UP220)
K261706
Karl Storz SE & CO. KG
Obstetrics & Gynecology · 55d
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 Sep 05, 2017
FluidSmart
K172048
Thermedx, LLC
Obstetrics & Gynecology · 61d
Cleared Jun 20, 2014
THERMEDX FLUID MANAGMENT SYSTEM
K133799
Thermedx, LLC
Obstetrics & Gynecology · 189d
Cleared Apr 04, 2013
HYSTEROSCOPY PUMP HM6
K123732
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 120d
Cleared Feb 06, 2012
AQUILEX FLUID CONTROL SYSTEM H112
K112642
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 147d
Cleared Jul 19, 2011
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
K110852
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 113d
Cleared Jul 23, 2010
THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000
K091939
Thermedx, LLC
Obstetrics & Gynecology · 388d
Cleared Aug 13, 2003
IUR FLUID MANAGEMENT SYSTEM
K031616
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 82d
Cleared Apr 30, 2003
AQUASENS FLUID MONITORING SYSTEM
K031213
Davol, Inc.
Obstetrics & Gynecology · 13d
Cleared Apr 10, 2003
HYSTEREOSCOPY PUMP HM4
K022449
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 258d
Cleared Jan 08, 2002
DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2
K011876
Circon Video
Obstetrics & Gynecology · 207d
Cleared Aug 16, 2001
AQUASENS FLUID MONITORING SYSTEM
K011069
Davol Inc., Sub. C. R. Bard, Inc.
Obstetrics & Gynecology · 129d
Cleared Nov 30, 2000
KARL STORZ HYSTEROMAT II
K000806
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 262d
Cleared Sep 13, 1999
DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO
K991799
Davol Inc., Sub. C. R. Bard, Inc.
Obstetrics & Gynecology · 110d
Cleared Feb 19, 1999
HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000
K982867
Davol Inc., Sub. C. R. Bard, Inc.
Obstetrics & Gynecology · 189d
Cleared Jan 14, 1999
HYS-SURGIFLATOR 150P
K983889
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 73d

About Product Code HIG - Regulatory Context

510(k) Submission Activity

57 total 510(k) submissions under product code HIG since 1984, with 57 receiving FDA clearance (average review time: 245 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 - HIG Product Code

Recent submissions under HIG have taken an average of 196 days to reach a decision - down from 247 days historically, suggesting improved FDA processing for this classification.

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