Strange Bile Duct Stone Exploration Set
FDA 510(k) K173687 · Cook Incorporated
510(k) numberK173687
Submission
- Device name
- Strange Bile Duct Stone Exploration Set
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- December 1, 2017
- Decision date
- December 15, 2017
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LQR – Dislodger, Stone, Biliary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Strange Bile Duct Stone Exploration Set cleared by the FDA?
Strange Bile Duct Stone Exploration Set (K173687) received a 510(k) decision of Unknown on December 15, 2017, 14 days after the submission was received.
What is the product code of K173687?
The FDA product code is LQR – Dislodger, Stone, Biliary, a Class II (moderate risk) device regulated under 21 CFR 876.5010.