Conmed Irrigation Nozzle
FDA 510(k) K050992 · Conmedcorp
510(k) numberK050992
Submission
- Device name
- Conmed Irrigation Nozzle
- Applicant
- Conmedcorp
Utica, NY, US - Received
- April 19, 2005
- Decision date
- July 14, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KPL – Colonic Irrigation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5220
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Conmed Irrigation Nozzle cleared by the FDA?
Conmed Irrigation Nozzle (K050992) received a 510(k) decision of Substantially Equivalent on July 14, 2005, 86 days after the submission was received.
What is the product code of K050992?
The FDA product code is KPL – Colonic Irrigation System, a Class II (moderate risk) device regulated under 21 CFR 876.5220.