The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Roth Net Retriever Product Line.
| Device ID | K182909 |
| 510k Number | K182909 |
| Device Name: | Roth Net Retriever Product Line |
| Classification | Snare, Flexible |
| Applicant | United States Endoscopy Group, Inc. 5976 Heisley Road Mentor, OH 44060 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin United States Endoscopy Group, Inc. 5976 Heisley Road Mentor, OH 44060 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-17 |
| Decision Date | 2018-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765013653 | K182909 | 000 |
| 10816765013646 | K182909 | 000 |
| 10724995182868 | K182909 | 000 |
| 10724995182851 | K182909 | 000 |