The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Biopsy Valve.
| Device ID | K111821 |
| 510k Number | K111821 |
| Device Name: | BIOPSY VALVE |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | ENDOCHOICE, INC. 11810 WILLS ROAD SUITE 100 Alpharetta, GA 30009 |
| Contact | Theron Gober |
| Correspondent | Theron Gober ENDOCHOICE, INC. 11810 WILLS ROAD SUITE 100 Alpharetta, GA 30009 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-28 |
| Decision Date | 2011-07-28 |
| Summary: | summary |