K133734 is an FDA 510(k) clearance for the SEAL SINGLE-USE BIOPSY VALVE, a Endoscopic Irrigation/suction System (Class II — Special Controls, product code OCX), submitted by Endochoice, Inc. (Alpharetta, US). The FDA issued a Cleared decision on March 19, 2014, 100 days after receiving the submission on December 9, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K133734 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 09, 2013 |
| Decision Date | March 19, 2014 |
| Days to Decision | 100 days |
| Submission Type | Special |
| 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. |