40 L High Flow Insufflator F108
FDA 510(k) K030837 · W.O.M. World of Medicine AG
510(k) numberK030837
Submission
- Device name
- 40 L High Flow Insufflator F108
- Applicant
- W.O.M. World of Medicine AG
Alexandria, VA, US - Received
- March 17, 2003
- Decision date
- February 5, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIF – Insufflator, Laparoscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1730
- Specialty
- Obstetrics/Gynecology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260209 | ENDOFLATOR+; Smart Smoke EvacuationHIF · Traditional | Karl Storz SE & CO. KG | 08/19/2026SE |
| K252584 | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)HIF · Traditional | Weyo Surgical Technology , Ltd. | 06/25/2026SE |
| K252318 | Insufflator (OPTO-IFL1000)HIF · Traditional | Guangdong Optomedic Technologies, Inc. | 04/16/2026SE |
| K250388 | Endoflator +HIF · Traditional | Karl Storz SE & CO. KG | 09/22/2025SE |
| K242772 | AirSurgN Insufflator (10030/AirSurgN)HIF · Traditional | SmartsurgN, Inc. | 04/11/2025SE |
| K243527 | High Flow Insufflation Unit (UHI-4)HIF · Traditional | Olympus Medical Systems Corporation | 01/13/2025SE |
| K242536 | TauTona Pneumoperitoneum Assist Device (TPAD)HIF · Traditional | Tautona Group | 10/15/2024SE |
| K232902 | EVA15 insufflatorHIF · Traditional | Palliare , Ltd. | 05/02/2024SE |
| K232464 | VereSee Optical Veres Needle SystemHIF · Traditional | Freyja Healthcare, LLC | 05/02/2024SE |
| K233020 | TauTona Pneumoperitoneum Assist Device (TPAD)HIF · Traditional | Tautona Group Research & Development, Co., LLC | 01/12/2024SE |
More from Tautona Group Research & Development, Co., LLC
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|---|---|---|
| K250795 | Purevue FMSHRX · Traditional | 12/05/2025SE |
| K201361 | PneumoclearHIF · Traditional | 07/29/2020SE |
| K173311 | ARTHRO-Pump PA304HRX · Traditional | 05/09/2018SE |
| K173489 | GYN-Pump PH304HIG · Traditional | 03/28/2018SE |
| K172040 | Aquilex Fluid Control System AQL-100SHIG · Special | 02/05/2018SE |
| K170784 | PneumoclearHIF · Traditional | 05/15/2017SE |
| K163320 | LAP-Pump PP110HET · Traditional | 03/21/2017SE |
| K153513 | Insufflator 50L FM134HIF · Traditional | 03/04/2016SE |
| K152109 | HD-Camera HDC1000FET · Traditional | 10/13/2015SE |
| K123732 | Hysteroscopy Pump HM6HIG · Special | 04/04/2013SE |
Questions and answers
When was 40 L High Flow Insufflator F108 cleared by the FDA?
40 L High Flow Insufflator F108 (K030837) received a 510(k) decision of Substantially Equivalent on February 5, 2004, 325 days after the submission was received.
What is the product code of K030837?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.