Lm- Lap 10 High Flow Insufflator
FDA 510(k) K914201 · Leisegang Medical, Inc.
510(k) numberK914201
Submission
- Device name
- Lm- Lap 10 High Flow Insufflator
- Applicant
- Leisegang Medical, Inc.
Boca Raton, FL, US - Received
- September 19, 1991
- Decision date
- January 9, 1992
- 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 |
|---|---|---|
| K990043 | Smoothlase Alexandrite Laser SystemGEX · Traditional | 02/11/1999SE |
| K940094 | Colposcopes and AccessoriesHEX · Traditional | 04/25/1995SE |
| K924134 | Leisegang Laparoscopic Irrigation System/AccessGCS · Traditional | 07/02/1993SE |
| K920217 | Max-E-VacGEI · Traditional | 07/23/1992SE |
| K912789 | LM-100/200LOW Flow InsufflatorHIG · Traditional | 09/20/1991SE |
| K913135 | LM-300TWINFSW · Traditional | 09/18/1991SE |
| K911212 | LM-150HT Light SourceESI · Traditional | 05/23/1991SE |
| K902313 | LM-1Z Zoom ScopeHEX · Traditional | 09/04/1990SE |
| K854767 | LM 1000GEH · Traditional | 01/24/1986SE |
Questions and answers
When was Lm- Lap 10 High Flow Insufflator cleared by the FDA?
Lm- Lap 10 High Flow Insufflator (K914201) received a 510(k) decision of Substantially Equivalent on January 9, 1992, 112 days after the submission was received.
What is the product code of K914201?
The FDA product code is HIF – Insufflator, Laparoscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1730.