Naude Urethral Stent
FDA 510(k) K912851 · Cook Urological, Inc.
510(k) numberK912851
Submission
- Device name
- Naude Urethral Stent
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- June 28, 1991
- Decision date
- January 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KOD – Catheter, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Naude Urethral Stent cleared by the FDA?
Naude Urethral Stent (K912851) received a 510(k) decision of Substantially Equivalent on January 30, 1992, 216 days after the submission was received.
What is the product code of K912851?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.