The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Injector Needle/snare.
| Device ID | K040961 |
| 510k Number | K040961 |
| Device Name: | INJECTOR NEEDLE/SNARE |
| Classification | Snare, Flexible |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Contact | Gretchen Y Cohen |
| Correspondent | Gretchen Y Cohen UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-13 |
| Decision Date | 2004-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995180826 | K040961 | 000 |
| 10724995180819 | K040961 | 000 |
| 10724995180802 | K040961 | 000 |
| 10724995180796 | K040961 | 000 |