Wilson-Cook Stricture Measuring Catheter
FDA 510(k) K973205 · Wilson-Cook Medical, Inc.
510(k) numberK973205
Submission
- Device name
- Wilson-Cook Stricture Measuring Catheter
- Applicant
- Wilson-Cook Medical, Inc.
Winston-Salem, NC, US - Received
- August 26, 1997
- Decision date
- November 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODD – Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To identify stones, tumors, or narrowing in the biliary tree.
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| K953967 | Endoscopic CatheterODD · Traditional | Act Medical, Inc. | 01/22/1996SE |
| K950700 | Bard Bilisystem Endoscopic Retrograde Cholangiopancreatography (Ercp) CannulaODD · Traditional | C.R. Bard, Inc. | 04/27/1995SE |
| K950729 | Olympus PR-23Q Disposable Cannula (Ball Tip)ODD · Traditional | Olympus America, Inc. | 03/17/1995SE |
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Questions and answers
When was Wilson-Cook Stricture Measuring Catheter cleared by the FDA?
Wilson-Cook Stricture Measuring Catheter (K973205) received a 510(k) decision of Substantially Equivalent on November 24, 1997, 90 days after the submission was received.
What is the product code of K973205?
The FDA product code is ODD – Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula, a Class II (moderate risk) device regulated under 21 CFR 876.1500.