The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Seal Single-use Biopsy Valve.
| Device ID | K133734 |
| 510k Number | K133734 |
| Device Name: | SEAL SINGLE-USE BIOPSY VALVE |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | ENDOCHOICE, INC. 11810 WILLS RD. Alpharetta, GA 30009 |
| Contact | Janna Babson |
| Correspondent | Janna Babson ENDOCHOICE, INC. 11810 WILLS RD. Alpharetta, GA 30009 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-09 |
| Decision Date | 2014-03-19 |
| Summary: | summary |