K203350 is an FDA 510(k) clearance for the ENDOtube. This device is classified as a Endoscopic Irrigation/suction System (Class II - Special Controls, product code OCX).
Submitted by Nissha Medical Technologies Sas (Conflans Ste Honorine, FR). The FDA issued a Cleared decision on September 29, 2021, 320 days after receiving the submission on November 13, 2020.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures..
| 510(k) Number | K203350 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2020 |
| Decision Date | September 29, 2021 |
| Days to Decision | 320 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OCX - Endoscopic Irrigation/suction System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures. |