Vasovapor
FDA 510(k) K101320 · Lexion Medical, LLC
510(k) numberK101320
Submission
- Device name
- Vasovapor
- Applicant
- Lexion Medical, LLC
St. Paul, MN, US - Received
- May 11, 2010
- Decision date
- June 24, 2010
- 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
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 |
|---|---|---|
| K191780 | AP50/30 Insufflator with Insuflow PortHIF · Traditional | 08/28/2019SE |
| K170799 | AP 50/30 Insufflator with Insuflow PortHIF · Traditional | 11/14/2017SE |
| K140263 | Insuflow Synergy Port, Insuflow Synergy XL PortHIF · Special | 03/05/2014SE |
| K132203 | Pneuview Xe Veryclear Gas Evacuation CannulaHIF · Traditional | 09/20/2013SE |
| K132204 | Insuflow Synergy XL PortHIF · Special | 08/22/2013SE |
| K120640 | Insuflow Synergy PortHIF · Traditional | 07/18/2012SE |
| K112357 | Vessel GuardianHIF · Traditional | 11/10/2011SE |
| K102136 | Vessel GuardianHIF · Traditional | 09/27/2010SE |
| K091366 | Insuflow DewheartHIF · Traditional | 09/03/2009SE |
| K090456 | InsuflowHIF · Traditional | 08/26/2009SE |
Questions and answers
When was Vasovapor cleared by the FDA?
Vasovapor (K101320) received a 510(k) decision of Substantially Equivalent on June 24, 2010, 44 days after the submission was received.
What is the product code of K101320?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.