HIG · Insufflator, Hysteroscopic
Obstetrics/Gynecology · 21 CFR 884.1700 · Class 2
Overview
| Product Code | HIG |
|---|---|
| Device Name | Insufflator, Hysteroscopic |
| Regulation | 21 CFR 884.1700 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.
Classification Rationale
(1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
Recent Cleared Devices (20 of 56)
Showing 20 most recent of 56 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251273 | Asurys Fluid Management System | Boston Scientific Corporation | Mar 27, 2026 | SESE |
| 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) | Hologic, Inc. | Jul 25, 2024 | SESE |
| K210628 | X-FLO Fluid Management System | Thermedx, LLC | Nov 4, 2021 | SESE |
| K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | Jul 22, 2020 | SESE |
| K180735 | Endomat Select | Karl Storz SE & CO. KG | Oct 31, 2018 | SESE |
| K180825 | Fluent Fluid Management System | Hologic, Inc. | Aug 3, 2018 | SESE |
| K173489 | GYN-Pump PH304 | W.O.M. World of Medicine GmbH | Mar 28, 2018 | SESE |
| K172040 | Aquilex Fluid Control System AQL-100S | W.O.M. World of Medicine GmbH | Feb 5, 2018 | SESE |
| K172048 | FluidSmart | Thermedx, LLC | Sep 5, 2017 | SESE |
| K133799 | THERMEDX FLUID MANAGMENT SYSTEM | Thermedx, LLC | Jun 20, 2014 | SESE |
| K123732 | HYSTEROSCOPY PUMP HM6 | W.O.M. World of Medicine AG | Apr 4, 2013 | SESE |
| K112642 | AQUILEX FLUID CONTROL SYSTEM H112 | W.O.M. World of Medicine AG | Feb 6, 2012 | SESE |
| K110852 | DOLPHIN 3 FLUID MANAGEMENT SYSTEM | Gyrus Acmi, Inc. | Jul 19, 2011 | SESE |
| K091939 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 | Thermedx, LLC | Jul 23, 2010 | SESE |
| K031616 | IUR FLUID MANAGEMENT SYSTEM | W.O.M. World of Medicine AG | Aug 13, 2003 | SESE |
| K031213 | AQUASENS FLUID MONITORING SYSTEM | Davol, Inc. | Apr 30, 2003 | SESE |
| K022449 | HYSTEREOSCOPY PUMP HM4 | W.O.M. World of Medicine AG | Apr 10, 2003 | SESE |
| K011876 | DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 | Circon Video | Jan 8, 2002 | SESE |
| K011069 | AQUASENS FLUID MONITORING SYSTEM | Davol Inc., Sub. C. R. Bard, Inc. | Aug 16, 2001 | SESE |
| K000806 | KARL STORZ HYSTEROMAT II | KARL STORZ Endoscopy-America, Inc. | Nov 30, 2000 | SESE |
Top Applicants
- W.O.M. World of Medicine GmbH — 6 clearances
- Davol Inc., Sub. C. R. Bard, Inc. — 5 clearances
- KARL STORZ Endoscopy-America, Inc. — 4 clearances
- Thermedx, LLC — 4 clearances
- W.O.M. World of Medicine AG — 4 clearances
