K200388 is an FDA 510(k) clearance for the Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector. This device is classified as a Endoscopic Irrigation/suction System (Class II - Special Controls, product code OCX).
Submitted by Ga Health Company Limited (Hong Kong, CN). The FDA issued a Cleared decision on April 14, 2020, 56 days after receiving the submission on February 18, 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 | K200388 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2020 |
| Decision Date | April 14, 2020 |
| Days to Decision | 56 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. |