K140315 is an FDA 510(k) clearance for the US ENDOSCOPY DISTAL ATTACHMENT CAP. This device is classified as a Endoscopic Irrigation/suction System (Class II - Special Controls, product code OCX).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on April 4, 2014, 53 days after receiving the submission on February 10, 2014.
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 | K140315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2014 |
| Decision Date | April 04, 2014 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| 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. |