K200103 is an FDA 510(k) clearance for the BIOTEQ Drainage Catheter Set (One Step Type). This device is classified as a Stents, Drains And Dilators For The Biliary Ducts (Class II - Special Controls, product code FGE).
Submitted by Bioteque Corporation (Taipei City, TW). The FDA issued a Cleared decision on October 9, 2020, 266 days after receiving the submission on January 17, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K200103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2020 |
| Decision Date | October 09, 2020 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGE - Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |