Product Code: HIG FDA class 2 21 CFR 884.1700

Insufflator, Hysteroscopic

Obstetrics/Gynecology

The Hysteroscopic Insufflator is a device used to distend the uterine cavity with gas (typically carbon dioxide) during hysteroscopic procedures, creating the space needed for visualization and operative access to the endometrial cavity. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HIG, regulated under 21 CFR 884.1700, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code HIG in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: HIG
Device Class: FDA class 2
Regulation Number: 884.1700
Medical Specialty: Obstetrics/Gynecology
Review Panel: OB
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 56 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251273	Asurys Fluid Management System	Mar 27, 2026	Substantially Equivalent	Boston Scientific Corporation
K240886	Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)	Jul 25, 2024	Substantially Equivalent	Hologic, Inc.
K210628	X-FLO Fluid Management System	Nov 04, 2021	Substantially Equivalent	Thermedx, LLC
K201355	Endomat Select, IBS Shaver Software, License	Jul 22, 2020	Substantially Equivalent	Karl Storz SE & CO. KG
K180735	Endomat Select	Oct 31, 2018	Substantially Equivalent	Karl Storz SE & CO. KG
K180825	Fluent Fluid Management System	Aug 03, 2018	Substantially Equivalent	Hologic, Inc.
K173489	GYN-Pump PH304	Mar 28, 2018	Substantially Equivalent	W.O.M. World of Medicine GmbH
K172040	Aquilex Fluid Control System AQL-100S	Feb 05, 2018	Substantially Equivalent	W.O.M. World of Medicine GmbH
K172048	FluidSmart	Sep 05, 2017	Substantially Equivalent	Thermedx, LLC
K133799	THERMEDX FLUID MANAGMENT SYSTEM	Jun 20, 2014	Substantially Equivalent	Thermedx, LLC
K123732	HYSTEROSCOPY PUMP HM6	Apr 04, 2013	Substantially Equivalent	W.O.M. World of Medicine AG
K112642	AQUILEX FLUID CONTROL SYSTEM H112	Feb 06, 2012	Substantially Equivalent	W.O.M. World of Medicine AG
K110852	DOLPHIN 3 FLUID MANAGEMENT SYSTEM	Jul 19, 2011	Substantially Equivalent	Gyrus Acmi, Inc.
K091939	THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000	Jul 23, 2010	Substantially Equivalent	Thermedx, LLC
K031616	IUR FLUID MANAGEMENT SYSTEM	Aug 13, 2003	Substantially Equivalent	W.O.M. World of Medicine AG
K031213	AQUASENS FLUID MONITORING SYSTEM	Apr 30, 2003	Substantially Equivalent	Davol, Inc.
K022449	HYSTEREOSCOPY PUMP HM4	Apr 10, 2003	Substantially Equivalent	W.O.M. World of Medicine AG
K011876	DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2	Jan 08, 2002	Substantially Equivalent	Circon Video
K011069	AQUASENS FLUID MONITORING SYSTEM	Aug 16, 2001	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K000806	KARL STORZ HYSTEROMAT II	Nov 30, 2000	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K991799	DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO	Sep 13, 1999	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K982867	HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000	Feb 19, 1999	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K983889	HYS-SURGIFLATOR 150P	Jan 14, 1999	Substantially Equivalent	W.O.M. World of Medicine GmbH
K970078	HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM	Dec 11, 1997	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K971492	AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR	Sep 05, 1997	Substantially Equivalent	Bei Medical Systems Co., Inc.
K964136	HYSTERO CO2-PNEU 2221	Jan 10, 1997	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K961091	KARL STORZ MODEL 203020 20 EQUIMAT	Oct 03, 1996	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K934866	HYS-SURGIMAT	Oct 20, 1995	Substantially Equivalent	W.O.M. World of Medicine GmbH
K933847	HYS-SURGIFLATOR VP	Aug 15, 1995	Substantially Equivalent	W.O.M. World of Medicine GmbH
K950961	KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP	May 25, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K941743	CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP	Apr 19, 1995	Substantially Equivalent	Cabot Medical Corp.
K924523	HYS-SURGIFLATOR	Apr 11, 1995	Substantially Equivalent	W.O.M. World of Medicine GmbH
K936231	THE KARL STORZ HAMOU ENDOMAT	Jan 24, 1995	Substantially Equivalent	Karl Storz Endoscopy
K933384	BARD HYSTERO-FLO II PUMP	Dec 30, 1994	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K933873	CONCEPT UNIVERSAL PUMP SYSTEM	Dec 29, 1994	Substantially Equivalent	Linvatec Corp.
K921871	HYSTEROMAT(TM) 3700	Dec 15, 1994	Substantially Equivalent	F.M. Wiest USA, Inc.
K930912	HYSTEROMED 100	Oct 17, 1994	Substantially Equivalent	Northgate Technologies, Inc.
K922632	WOM HYSTEROFLATOR OP	Mar 25, 1994	Substantially Equivalent	W.O.M. GmbH
K931606	7-510-25 HYSTEROMED TUBING KIT	Jan 24, 1994	Substantially Equivalent	Nortech
K922197	INSUFFLATOR TUBING KIT	Sep 24, 1993	Substantially Equivalent	O.R. Concepts, Inc.
K912498	THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR	Dec 18, 1991	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K911844	HYSTEROFLATOR 1500	Nov 21, 1991	Substantially Equivalent	F.M. Wiest USA, Inc.
K912789	LM-100/200LOW FLOW INSUFFLATOR	Sep 20, 1991	Substantially Equivalent	Leisegang Medical, Inc.
K905495	HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR	Apr 29, 1991	Substantially Equivalent	Frigitronics, Inc.
K905706	GYN-1500 HYSTEROSCOPIC INUFFLATOR	Feb 28, 1991	Substantially Equivalent	Circon Acmi
K901288	DAVOL SCOPE IRRIGATION SYSTEM	Oct 10, 1990	Substantially Equivalent	C.R. Bard, Inc.
K900908	CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200	May 21, 1990	Substantially Equivalent	Zimmer, Inc.
K894259	REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA	Mar 05, 1990	Substantially Equivalent	Washington Regulatory Services
K895659	HUI MINI-FLEX	Dec 19, 1989	Substantially Equivalent	Unimar, Inc.
K895907	HYSTEROFLATOR 2001	Dec 14, 1989	Substantially Equivalent	Cabot Medical Corp.
K892001	DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE	Jun 16, 1989	Substantially Equivalent	Dexide, Inc.
K891028	UTERINE CANNULA - KAHN, JARCO, CORSON, RATCHET	Mar 17, 1989	Substantially Equivalent	Zinnanti Surgical Instruments, Inc.
K881680	ACKRAD H/S PROCEDURE TRAY	Jul 15, 1988	Unknown	Ackrad Laboratories
K873527	DECHERNEY HYSTEROSCOPY PUMP SYSTEM	Feb 26, 1988	Substantially Equivalent	Cabot Medical Corp.
K872860	INSUFFLATOR TUBING	Nov 16, 1987	Substantially Equivalent	Medline Industries, Inc.
K842943	AXCAN UTERINE SUCCION INJECTOR	Sep 21, 1984	Substantially Equivalent	Axcan Scientific Corp.