K183171 is an FDA 510(k) clearance for the ScopeSeal Duodenoscope Protective Device. This device is classified as a Endoscopic Contamination Prevention Sheath (Class II - Special Controls, product code ODB).
Submitted by Gi Scientific, LLC (Arlington, US). The FDA issued a Cleared decision on October 8, 2019, 326 days after receiving the submission on November 16, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Protect An Endoscope From Contamination By Providing A Barrier Between The Body And The Endoscope..
| 510(k) Number | K183171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2018 |
| Decision Date | October 08, 2019 |
| Days to Decision | 326 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODB - Endoscopic Contamination Prevention Sheath |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Protect An Endoscope From Contamination By Providing A Barrier Between The Body And The Endoscope. |