The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Lariat Snare.
| Device ID | K151197 |
| 510k Number | K151197 |
| Device Name: | Lariat Snare |
| Classification | Snare, Flexible |
| Applicant | UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY ROAD Mentor, OH 44060 |
| Contact | Sagar Pimpalwar |
| Correspondent | Sagar Pimpalwar UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY ROAD 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 | 2015-05-05 |
| Decision Date | 2015-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765015244 | K151197 | 000 |
| 10816765015237 | K151197 | 000 |
| 10724995182639 | K151197 | 000 |
| 10724995182585 | K151197 | 000 |
| 10724995182578 | K151197 | 000 |