RP Cutting Needle
FDA 510(k) K092059 · Riverpoint Medical
510(k) numberK092059
Submission
- Device name
- RP Cutting Needle
- Applicant
- Riverpoint Medical
Portland, OR, US - Received
- July 7, 2009
- Decision date
- September 24, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was RP Cutting Needle cleared by the FDA?
RP Cutting Needle (K092059) received a 510(k) decision of Substantially Equivalent on September 24, 2009, 79 days after the submission was received.
What is the product code of K092059?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.