The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Endochoice Select Injection Needle.
| Device ID | K151475 |
| 510k Number | K151475 |
| Device Name: | EndoChoice Select Injection Needle |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | ENDOCHOICE, INC. 11810 WILLS RD. Alpharetta, GA 30009 |
| Contact | Theron Gober |
| Correspondent | Theron Gober ENDOCHOICE, INC. 11810 WILLS RD. Alpharetta, GA 30009 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-02 |
| Decision Date | 2016-02-08 |
| Summary: | summary |