LM-100/200LOW Flow Insufflator
FDA 510(k) K912789 · Leisegang Medical, Inc.
510(k) numberK912789
Submission
- Device name
- LM-100/200LOW Flow Insufflator
- Applicant
- Leisegang Medical, Inc.
Boca Raton, FL, US - Received
- June 25, 1991
- Decision date
- September 20, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HIG – Insufflator, Hysteroscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1700
- Specialty
- Obstetrics/Gynecology
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| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…HIG · Traditional | Hologic, Inc. | 07/25/2024SE |
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| K180825 | Fluent Fluid Management SystemHIG · Traditional | Hologic, Inc. | 08/03/2018SE |
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| K172040 | Aquilex Fluid Control System AQL-100SHIG · Special | W.O.M. World of Medicine GmbH | 02/05/2018SE |
| K172048 | FluidSmartHIG · Special | Thermedx, LLC | 09/05/2017SE |
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| K990043 | Smoothlase Alexandrite Laser SystemGEX · Traditional | 02/11/1999SE |
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| K924134 | Leisegang Laparoscopic Irrigation System/AccessGCS · Traditional | 07/02/1993SE |
| K920217 | Max-E-VacGEI · Traditional | 07/23/1992SE |
| K914201 | Lm- Lap 10 High Flow InsufflatorHIF · Traditional | 01/09/1992SE |
| 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-100/200LOW Flow Insufflator cleared by the FDA?
LM-100/200LOW Flow Insufflator (K912789) received a 510(k) decision of Substantially Equivalent on September 20, 1991, 87 days after the submission was received.
What is the product code of K912789?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.