Model 700 Laparoscopic Electronic Insufflator
FDA 510(k) K912044 · Multigon Industries, Inc.
510(k) numberK912044
Submission
- Device name
- Model 700 Laparoscopic Electronic Insufflator
- Applicant
- Multigon Industries, Inc.
Mt. Vernon, NY, US - Received
- May 8, 1991
- Decision date
- June 24, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HIF – Insufflator, Laparoscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1730
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIF
| 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
| 510(k) | Device | Decision |
|---|---|---|
| K052067 | Doppler Guided Proctoscope, Model 500HJAF · Traditional | 08/29/2005SE |
| K051739 | Pocket Transcranial and Vascular Doppler Spectrum Analyzer, Model 500P; PW Doppler…IYN · Traditional | 07/28/2005SE |
| K881263 | Model 500A Vascular Spectrum Analyzer W/DopplerHGL · Traditional | 01/05/1990SE |
| K882755 | Model 500V Vascular Spectrum AnalyzerIYN · Traditional | 11/29/1988SE |
| K863589 | Model 600 Vascular Duplex ImagerDXK · Traditional | 06/24/1987SE |
| K860435 | Model 500A Vascular Spectrum Analyzer W/Cw DopplerDPT · Traditional | 05/05/1986SE |
| K852680 | Triton Laparoscopic Coagulator Insufflator & LavagHET · Traditional | 12/23/1985SE |
Questions and answers
When was Model 700 Laparoscopic Electronic Insufflator cleared by the FDA?
Model 700 Laparoscopic Electronic Insufflator (K912044) received a 510(k) decision of Substantially Equivalent on June 24, 1991, 47 days after the submission was received.
What is the product code of K912044?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.