Decherney Hysteroscopy Pump System
FDA 510(k) K873527 · Cabot Medical Corp.
510(k) numberK873527
Submission
- Device name
- Decherney Hysteroscopy Pump System
- Applicant
- Cabot Medical Corp.
Langhorne, PA, US - Received
- September 1, 1987
- Decision date
- February 26, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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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Questions and answers
When was Decherney Hysteroscopy Pump System cleared by the FDA?
Decherney Hysteroscopy Pump System (K873527) received a 510(k) decision of Substantially Equivalent on February 26, 1988, 178 days after the submission was received.
What is the product code of K873527?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.