Product code HIF
- Device name
- Insufflator, Laparoscopic
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.1730
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252318 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | 2026-04-16 |
| K250388 | ENDOFLATOR + | Karl Storz SE & CO. KG | 2025-09-22 |
| K242772 | AirSurgN Insufflator (10030/AirSurgN) | SmartsurgN, Inc. | 2025-04-11 |
| K243527 | High Flow Insufflation Unit (UHI-4) | Olympus Medical Systems Corporation | 2025-01-13 |
| K242536 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group | 2024-10-15 |
| K232902 | EVA15 insufflator | Palliare , Ltd. | 2024-05-02 |
| K232464 | VereSee Optical Veres Needle System | Freyja Healthcare, LLC | 2024-05-02 |
| K233020 | TauTona Pneumoperitoneum Assist Device (TPAD) | Tautona Group Research & Development, Co., LLC | 2024-01-12 |
| K232401 | Disposable Veress Needles | Hangzhou Kangji Medical Instrument Co., Ltd. | 2023-12-14 |
| K231342 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | 2023-09-20 |
| K230239 | AirSeal iFS System; AirSeal dV Solution | Conmed Corporation | 2023-09-20 |
| K231407 | StarFin | Premium Medical Technology, LLC | 2023-08-29 |
| K222812 | Insufflator | Scivita Medical Technology Co., Ltd. | 2023-05-16 |
| K221995 | Gas Insufflator | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2023-03-28 |
| K222901 | EVA15 insufflator | Palliare , Ltd. | 2023-01-27 |
| K212786 | LevaLap Laparoscopic Access Device | Core Access Surgical Technologies, Inc. | 2022-02-23 |
| K211104 | AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set | Conmed Corporation | 2021-08-19 |
| K202799 | EVA15 | Palliare , Ltd. | 2020-10-21 |
| K201361 | PNEUMOCLEAR | W.O.M. World of Medicine GmbH | 2020-07-29 |
| K193520 | EVA 15 Insufflator | Palliare , Ltd. | 2020-07-23 |
| K193339 | GTK Veress Needles | Guangzhou T.K Medical Instrument Co., Ltd. | 2020-01-30 |
| K191780 | AP50/30 Insufflator with Insuflow Port | Lexion Medical, LLC | 2019-08-28 |
| K190303 | AirSeal | Conmed Corporation | 2019-03-28 |
| K172835 | GRI-Alleset Veress Needle | Gri Medical and Electronic Technology Co., Ltd. | 2018-06-11 |
| K172516 | SurgiQuest AIRSEAL iFS System | Conmed Corporation | 2018-03-16 |
| K173545 | TEMED Gas Diffuser | Temed | 2018-02-14 |
| K170799 | AP 50/30 Insufflator with Insuflow Port | Lexion Medical, LLC | 2017-11-14 |
| K162582 | HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit | Fisher & Paykel Healthcare | 2017-06-23 |
| K171139 | LaparoLight Veress Needle | Buffalo Filter, LLC | 2017-05-18 |
| K170784 | PNEUMOCLEAR | W.O.M. World of Medicine GmbH | 2017-05-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10845854045633 | AIRSEAL | Conmed Corporation | 2024-03-27 |
| 10845854045367 | CONMED | Conmed Corporation | 2023-12-04 |
| 09420012433978 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2023-07-06 |
| 10850082007834 | Insufflator Filter Assembly | ARMM INC. | 2023-06-08 |
| 10850082007193 | Insufflator Filter Assembly | ARMM INC. | 2023-06-08 |
| 10850082007186 | Filter Assembly | ARMM INC. | 2023-06-08 |
| 14026704912497 | WECK | TELEFLEX INCORPORATED | 2023-02-24 |
| 07613327147902 | NA | STRYKER CORPORATION | 2022-12-08 |
| 07613327147971 | NA | STRYKER CORPORATION | 2022-12-08 |
| 10851885004594 | AIRSEAL | Conmed Corporation | 2021-09-08 |
| 10845854051405 | AirSeal | Conmed Corporation | 2021-08-22 |
| 14026704644961 | WECK | TELEFLEX INCORPORATED | 2019-04-16 |
| 14026704644954 | WECK | TELEFLEX INCORPORATED | 2019-04-16 |
| 10845854045435 | AIRSEAL | Conmed Corporation | 2017-08-31 |
| 10851885004006 | AIRSEAL | Conmed Corporation | 2016-09-24 |
| 10851885004013 | AIRSEAL | Conmed Corporation | 2016-09-24 |
| 10884521080799 | Iotec | Covidien LP | 2016-09-24 |
| 10845854045343 | CPS | Conmed Corporation | 2016-09-24 |
| 10845854045220 | CONMED | Conmed Corporation | 2016-09-24 |
| M430S64040051 | COMEG MEDICAL | SOPRO | 2016-09-24 |
| M430S64040041 | COMEG MEDICAL | SOPRO | 2016-09-24 |
| M430S64030111 | COMEG MEDICAL | SOPRO | 2016-09-24 |
| M430S64030081 | COMEG MEDICAL | SOPRO | 2016-09-24 |
| M430S64020081 | COMEG MEDICAL | SOPRO | 2016-09-24 |
| M430S64020041 | COMEG MEDICAL | SOPRO | 2016-09-24 |
| 07613327055627 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613327055658 | Pneumosure | STRYKER CORPORATION | 2016-09-23 |
| 07613327055641 | Pneumosure | STRYKER CORPORATION | 2016-09-23 |
| 07613327055634 | Pneumosure | STRYKER CORPORATION | 2016-09-23 |
| 10705036013426 | ENDOPATH | ETHICON ENDO-SURGERY, LLC | 2016-07-15 |