Bonee Needle for Bladder Injections, MODELSNBI035, NBI070
FDA 510(k) K090217 · Coloplast A/S
510(k) numberK090217
Submission
- Device name
- Bonee Needle for Bladder Injections, MODELSNBI035, NBI070
- Applicant
- Coloplast A/S
Plymouth, MN, US - Received
- January 29, 2009
- Decision date
- April 23, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FBK – Endoscopic Injection Needle, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
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Questions and answers
When was Bonee Needle for Bladder Injections, MODELSNBI035, NBI070 cleared by the FDA?
Bonee Needle for Bladder Injections, MODELSNBI035, NBI070 (K090217) received a 510(k) decision of Substantially Equivalent on April 23, 2009, 84 days after the submission was received.
What is the product code of K090217?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.