Controlled Distention Irrigation System Cdis 200
FDA 510(k) K900908 · Zimmer, Inc.
510(k) numberK900908
Submission
- Device name
- Controlled Distention Irrigation System Cdis 200
- Applicant
- Zimmer, Inc.
Dover, OH, US - Received
- February 27, 1990
- Decision date
- May 21, 1990
- 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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| 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 Controlled Distention Irrigation System Cdis 200 cleared by the FDA?
Controlled Distention Irrigation System Cdis 200 (K900908) received a 510(k) decision of Substantially Equivalent on May 21, 1990, 83 days after the submission was received.
What is the product code of K900908?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.