Howell Biliary Aspiration Needle
FDA 510(k) K153763 · Wilson-Cook Medical, Inc.
510(k) numberK153763
Submission
- Device name
- Howell Biliary Aspiration Needle
- Applicant
- Wilson-Cook Medical, Inc.
Winston-Salem, NC, US - Received
- December 30, 2015
- Decision date
- April 6, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCK – Instrument, Biopsy, Suction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Howell Biliary Aspiration Needle cleared by the FDA?
Howell Biliary Aspiration Needle (K153763) received a 510(k) decision of Substantially Equivalent on April 6, 2017, 463 days after the submission was received.
What is the product code of K153763?
The FDA product code is FCK – Instrument, Biopsy, Suction, a Class II (moderate risk) device regulated under 21 CFR 876.1075.