Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart B — Obstetrical and Gynecological Diagnostic Devices](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices) → [21 CFR 884.1700](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1700) → HIG — Insufflator, Hysteroscopic # HIG · Insufflator, Hysteroscopic _Obstetrics/Gynecology · 21 CFR 884.1700 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG ## Overview - **Product Code:** HIG - **Device Name:** Insufflator, Hysteroscopic - **Regulation:** [21 CFR 884.1700](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1700) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **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](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K251273.md) | Asurys Fluid Management System | Boston Scientific Corporation | Mar 27, 2026 | SESE | | [K240886](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K240886.md) | 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](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K210628.md) | X-FLO Fluid Management System | Thermedx, LLC | Nov 4, 2021 | SESE | | [K201355](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K201355.md) | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | Jul 22, 2020 | SESE | | [K180735](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K180735.md) | Endomat Select | Karl Storz SE & CO. KG | Oct 31, 2018 | SESE | | [K180825](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K180825.md) | Fluent Fluid Management System | Hologic, Inc. | Aug 3, 2018 | SESE | | [K173489](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K173489.md) | GYN-Pump PH304 | W.O.M. World of Medicine GmbH | Mar 28, 2018 | SESE | | [K172040](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K172040.md) | Aquilex Fluid Control System AQL-100S | W.O.M. World of Medicine GmbH | Feb 5, 2018 | SESE | | [K172048](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K172048.md) | FluidSmart | Thermedx, LLC | Sep 5, 2017 | SESE | | [K133799](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K133799.md) | THERMEDX FLUID MANAGMENT SYSTEM | Thermedx, LLC | Jun 20, 2014 | SESE | | [K123732](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K123732.md) | HYSTEROSCOPY PUMP HM6 | W.O.M. World of Medicine AG | Apr 4, 2013 | SESE | | [K112642](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K112642.md) | AQUILEX FLUID CONTROL SYSTEM H112 | W.O.M. World of Medicine AG | Feb 6, 2012 | SESE | | [K110852](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K110852.md) | DOLPHIN 3 FLUID MANAGEMENT SYSTEM | Gyrus Acmi, Inc. | Jul 19, 2011 | SESE | | [K091939](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K091939.md) | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 | Thermedx, LLC | Jul 23, 2010 | SESE | | [K031616](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K031616.md) | IUR FLUID MANAGEMENT SYSTEM | W.O.M. World of Medicine AG | Aug 13, 2003 | SESE | | [K031213](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K031213.md) | AQUASENS FLUID MONITORING SYSTEM | Davol, Inc. | Apr 30, 2003 | SESE | | [K022449](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K022449.md) | HYSTEREOSCOPY PUMP HM4 | W.O.M. World of Medicine AG | Apr 10, 2003 | SESE | | [K011876](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K011876.md) | DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 | Circon Video | Jan 8, 2002 | SESE | | [K011069](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K011069.md) | AQUASENS FLUID MONITORING SYSTEM | Davol Inc., Sub. C. R. Bard, Inc. | Aug 16, 2001 | SESE | | [K000806](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG/K000806.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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