The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Ec Single Use, Polypectomy Snare.
| Device ID | K123223 |
| 510k Number | K123223 |
| Device Name: | EC SINGLE USE, POLYPECTOMY SNARE |
| Classification | Snare, Flexible |
| Applicant | ENDOCHOICE, INC. 1914 J.N. PEASE PLACE Charlotte, NC 28262 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman ENDOCHOICE, INC. 1914 J.N. PEASE PLACE Charlotte, NC 28262 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-15 |
| Decision Date | 2013-01-10 |
| Summary: | summary |