Wilson-Cook Aspiration Handle
FDA 510(k) K903668 · Wilson-Cook Medical, Inc.
510(k) numberK903668
Submission
- Device name
- Wilson-Cook Aspiration Handle
- Applicant
- Wilson-Cook Medical, Inc.
Winston-Salem, NC, US - Received
- August 13, 1990
- Decision date
- October 15, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Wilson-Cook Aspiration Handle cleared by the FDA?
Wilson-Cook Aspiration Handle (K903668) received a 510(k) decision of Substantially Equivalent on October 15, 1990, 63 days after the submission was received.
What is the product code of K903668?
The FDA product code is FBK – Endoscopic Injection Needle, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.