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 884.1730](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1730) → HIF — Insufflator, Laparoscopic # HIF · Insufflator, Laparoscopic _Obstetrics/Gynecology · 21 CFR 884.1730 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF ## Overview - **Product Code:** HIF - **Device Name:** Insufflator, Laparoscopic - **Regulation:** [21 CFR 884.1730](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1730) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) ## Identification A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it. ## Classification Rationale (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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 177) Showing 20 most recent of 177 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252318](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K252318.md) | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | Apr 16, 2026 | SESE | | [K250388](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K250388.md) | ENDOFLATOR + | Karl Storz SE & CO. KG | Sep 22, 2025 | SESE | | [K242772](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K242772.md) | AirSurgN Insufflator (10030/AirSurgN) | SmartsurgN, Inc. | Apr 11, 2025 | SESE | | [K243527](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K243527.md) | High Flow Insufflation Unit (UHI-4) | Olympus Medical Systems Corporation | Jan 13, 2025 | SESE | | [K242536](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K242536.md) | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group | Oct 15, 2024 | SESE | | [K232902](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K232902.md) | EVA15 insufflator | Palliare , Ltd. | May 2, 2024 | SESE | | [K232464](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K232464.md) | VereSee Optical Veres Needle System | Freyja Healthcare, LLC | May 2, 2024 | SESE | | [K233020](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K233020.md) | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Development, Co., LLC | Jan 12, 2024 | SESE | | [K232401](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K232401.md) | Disposable Veress Needles | Hangzhou Kangji Medical Instrument Co., Ltd. | Dec 14, 2023 | SESE | | [K231342](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K231342.md) | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | Sep 20, 2023 | SESE | | [K230239](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K230239.md) | AirSeal iFS System; AirSeal dV Solution | Conmed Corporation | Sep 20, 2023 | SESE | | [K231407](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K231407.md) | StarFin | Premium Medical Technology, LLC | Aug 29, 2023 | SESE | | [K222812](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K222812.md) | Insufflator | Scivita Medical Technology Co., Ltd. | May 16, 2023 | SESE | | [K221995](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K221995.md) | Gas Insufflator | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Mar 28, 2023 | SESE | | [K222901](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K222901.md) | EVA15 insufflator | Palliare , Ltd. | Jan 27, 2023 | SESE | | [K212786](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K212786.md) | LevaLap Laparoscopic Access Device | Core Access Surgical Technologies, Inc. | Feb 23, 2022 | SESE | | [K211104](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K211104.md) | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set | Conmed Corporation | Aug 19, 2021 | SESE | | [K202799](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K202799.md) | EVA15 | Palliare , Ltd. | Oct 21, 2020 | SESE | | [K201361](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K201361.md) | PNEUMOCLEAR | W.O.M. World of Medicine GmbH | Jul 29, 2020 | SESE | | [K193520](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF/K193520.md) | EVA 15 Insufflator | Palliare , Ltd. | Jul 23, 2020 | SESE | ## Top Applicants - Northgate Technologies, Inc. — 16 clearances - Lexion Medical, LLC — 12 clearances - KARL STORZ Endoscopy-America, Inc. — 9 clearances - Richard Wolf Medical Instruments Corp. — 7 clearances - W.O.M. World of Medicine GmbH — 7 clearances --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIF) **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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