Dolphin 3 Fluid Management System
FDA 510(k) K110852 · Gyrus Acmi, Inc.
510(k) numberK110852
Submission
- Device name
- Dolphin 3 Fluid Management System
- Applicant
- Gyrus Acmi, Inc.
Southborough, MA, US - Received
- March 28, 2011
- Decision date
- July 19, 2011
- 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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| K261706 | Endomat Select (UP220)HIG · Traditional | Karl Storz Se & Co. KG | 07/16/2026SE |
| K251273 | Asurys Fluid Management SystemHIG · Traditional | Boston Scientific Corporation | 03/27/2026SE |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…HIG · Traditional | Hologic, Inc. | 07/25/2024SE |
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| K180735 | Endomat SelectHIG · Traditional | Karl Storz SE & CO. KG | 10/31/2018SE |
| K180825 | Fluent Fluid Management SystemHIG · Traditional | Hologic, Inc. | 08/03/2018SE |
| K173489 | GYN-Pump PH304HIG · Traditional | W.O.M. World of Medicine GmbH | 03/28/2018SE |
| 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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Questions and answers
When was Dolphin 3 Fluid Management System cleared by the FDA?
Dolphin 3 Fluid Management System (K110852) received a 510(k) decision of Substantially Equivalent on July 19, 2011, 113 days after the submission was received.
What is the product code of K110852?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.