HIG · Class II · 21 CFR 884.1700

FDA Product Code HIG: Insufflator, Hysteroscopic

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Cabot Medical Corp. and W.O.M. World of Medicine GmbH.

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 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 Jul 19, 2011
DOLPHIN 3 FLUID MANAGEMENT SYSTEM
K110852
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 113d
Cleared Apr 30, 2003
AQUASENS FLUID MONITORING SYSTEM
K031213
Davol, Inc.
Obstetrics & Gynecology · 13d
Cleared Nov 30, 2000
KARL STORZ HYSTEROMAT II
K000806
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 262d
Cleared Jan 10, 1997
HYSTERO CO2-PNEU 2221
K964136
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 87d
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 Apr 19, 1995
CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP
K941743
Cabot Medical Corp.
Obstetrics & Gynecology · 377d
Cleared Jan 24, 1995
THE KARL STORZ HAMOU ENDOMAT
K936231
Karl Storz Endoscopy
Obstetrics & Gynecology · 391d
Cleared Dec 29, 1994
CONCEPT UNIVERSAL PUMP SYSTEM
K933873
Linvatec Corp.
Obstetrics & Gynecology · 507d
Cleared Oct 17, 1994
HYSTEROMED 100
K930912
Northgate Technologies, Inc.
Obstetrics & Gynecology · 602d
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 Dec 14, 1989
HYSTEROFLATOR 2001
K895907
Cabot Medical Corp.
Obstetrics & Gynecology · 69d
Cleared Jun 16, 1989
DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE
K892001
Dexide, Inc.
Obstetrics & Gynecology · 80d
Cleared Mar 17, 1989
UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET
K891028
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 17d

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 →