Hysteroflator 1500
FDA 510(k) K911844 · F.M. Wiest USA, Inc.
510(k) numberK911844
Submission
- Device name
- Hysteroflator 1500
- Applicant
- F.M. Wiest USA, Inc.
Oradel, NJ, US - Received
- April 25, 1991
- Decision date
- November 21, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 |
More from Thermedx, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K921871 | Hysteromat(Tm) 3700HIG · Traditional | 12/15/1994SE |
| K920574 | Camsys 6300EXQ · Traditional | 02/17/1993SE |
| K920575 | Merkur 4000FAP · Traditional | 07/23/1992SE |
| K915751 | Ureteromat 4400EZN · Traditional | 04/24/1992SE |
| K912071 | Space(Tm) 7500IKN · Traditional | 07/09/1991SE |
| K910883 | Laparoflator Electronic 3509HIF · Traditional | 03/29/1991SE |
| K875137 | Laparoflator 3000, Standard and ElectronicHES · Traditional | 03/02/1988SE |
| K871181 | Arthrocombi 5003HRX · Traditional | 09/29/1987SE |
| K871180 | Arthro Automat 5002HRX · Traditional | 09/29/1987SE |
| K865066 | ArthroflatorHRX · Traditional | 04/20/1987SE |
Questions and answers
When was Hysteroflator 1500 cleared by the FDA?
Hysteroflator 1500 (K911844) received a 510(k) decision of Substantially Equivalent on November 21, 1991, 210 days after the submission was received.
What is the product code of K911844?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.