Imbibe Needle
FDA 510(k) K153306 · Orthovita, Inc.
510(k) numberK153306
Submission
- Device name
- Imbibe Needle
- Applicant
- Orthovita, Inc.
Malver, PA, US - Received
- November 16, 2015
- Decision date
- December 18, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Imbibe Needle cleared by the FDA?
Imbibe Needle (K153306) received a 510(k) decision of Substantially Equivalent on December 18, 2015, 32 days after the submission was received.
What is the product code of K153306?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.