K202583 is an FDA 510(k) clearance for the BioShield biopsy valve EUS - Linear. This device is classified as a Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula (Class II - Special Controls, product code ODD).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on November 6, 2020, 59 days after receiving the submission on September 8, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Identify Stones, Tumors, Or Narrowing In The Biliary Tree..
| 510(k) Number | K202583 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2020 |
| Decision Date | November 06, 2020 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODD — Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Identify Stones, Tumors, Or Narrowing In The Biliary Tree. |