Coloplast Uro 2002 Night Drainage System
FDA 510(k) K844684 · Coloplast A/S
510(k) numberK844684
Submission
- Device name
- Coloplast Uro 2002 Night Drainage System
- Applicant
- Coloplast A/S
Tampa, FL, US - Received
- November 30, 1984
- Decision date
- January 8, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNX – Collector, Urine, (And Accessories) For Indwelling Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Coloplast Uro 2002 Night Drainage System cleared by the FDA?
Coloplast Uro 2002 Night Drainage System (K844684) received a 510(k) decision of Substantially Equivalent on January 8, 1985, 39 days after the submission was received.
What is the product code of K844684?
The FDA product code is KNX – Collector, Urine, (And Accessories) For Indwelling Catheter, a Class II (moderate risk) device regulated under 21 CFR 876.5250.