The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Roth Net Retriever.
| Device ID | K122462 |
| 510k Number | K122462 |
| Device Name: | ROTH NET RETRIEVER |
| Classification | Snare, Flexible |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor, OH 44060 |
| Contact | Carroll Martin |
| Correspondent | Carroll Martin UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. 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 | 2012-08-13 |
| Decision Date | 2012-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765013516 | K122462 | 000 |
| 10724995182691 | K122462 | 000 |
| 10724995182684 | K122462 | 000 |
| 10724995182677 | K122462 | 000 |
| 10724995182547 | K122462 | 000 |
| 10724995182530 | K122462 | 000 |
| 10724995182523 | K122462 | 000 |
| 10724995182516 | K122462 | 000 |
| 10724995182509 | K122462 | 000 |
| 10724995182493 | K122462 | 000 |
| 10724995182936 | K122462 | 000 |
| 10724995182929 | K122462 | 000 |
| 10724995182912 | K122462 | 000 |
| 10724995182707 | K122462 | 000 |
| 10724995182714 | K122462 | 000 |
| 10724995182721 | K122462 | 000 |
| 10816765013509 | K122462 | 000 |
| 10816765012847 | K122462 | 000 |
| 10816765012830 | K122462 | 000 |
| 10816765012007 | K122462 | 000 |
| 10816765011994 | K122462 | 000 |
| 10816765011987 | K122462 | 000 |
| 10816765011970 | K122462 | 000 |
| 10724995182776 | K122462 | 000 |
| 10724995182769 | K122462 | 000 |
| 10724995182752 | K122462 | 000 |
| 10724995182745 | K122462 | 000 |
| 10724995182738 | K122462 | 000 |
| 10724995182905 | K122462 | 000 |