HIF · Insufflator, Laparoscopic
Obstetrics/Gynecology · 21 CFR 884.1730 · Class 2
Overview
| Product Code | HIF |
|---|---|
| Device Name | Insufflator, Laparoscopic |
| Regulation | 21 CFR 884.1730 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | Apr 16, 2026 | SESE |
| K250388 | ENDOFLATOR + | Karl Storz SE & CO. KG | Sep 22, 2025 | SESE |
| K242772 | AirSurgN Insufflator (10030/AirSurgN) | SmartsurgN, Inc. | Apr 11, 2025 | SESE |
| K243527 | High Flow Insufflation Unit (UHI-4) | Olympus Medical Systems Corporation | Jan 13, 2025 | SESE |
| K242536 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group | Oct 15, 2024 | SESE |
| K232902 | EVA15 insufflator | Palliare , Ltd. | May 2, 2024 | SESE |
| K232464 | VereSee Optical Veres Needle System | Freyja Healthcare, LLC | May 2, 2024 | SESE |
| K233020 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Development, Co., LLC | Jan 12, 2024 | SESE |
| K232401 | Disposable Veress Needles | Hangzhou Kangji Medical Instrument Co., Ltd. | Dec 14, 2023 | SESE |
| K231342 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | Sep 20, 2023 | SESE |
| K230239 | AirSeal iFS System; AirSeal dV Solution | Conmed Corporation | Sep 20, 2023 | SESE |
| K231407 | StarFin | Premium Medical Technology, LLC | Aug 29, 2023 | SESE |
| K222812 | Insufflator | Scivita Medical Technology Co., Ltd. | May 16, 2023 | SESE |
| K221995 | Gas Insufflator | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Mar 28, 2023 | SESE |
| K222901 | EVA15 insufflator | Palliare , Ltd. | Jan 27, 2023 | SESE |
| K212786 | LevaLap Laparoscopic Access Device | Core Access Surgical Technologies, Inc. | Feb 23, 2022 | SESE |
| K211104 | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set | Conmed Corporation | Aug 19, 2021 | SESE |
| K202799 | EVA15 | Palliare , Ltd. | Oct 21, 2020 | SESE |
| K201361 | PNEUMOCLEAR | W.O.M. World of Medicine GmbH | Jul 29, 2020 | SESE |
| K193520 | 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
