The following data is part of a premarket notification filed by United States Endoscopy with the FDA for Monofilament Polypectomy Snare.
| Device ID | K140763 |
| 510k Number | K140763 |
| Device Name: | MONOFILAMENT POLYPECTOMY SNARE |
| Classification | Snare, Flexible |
| Applicant | UNITED STATES ENDOSCOPY 5976 HEISLEY ROAD Mentor, OH 44060 |
| Contact | Sagar D Pimpalwar |
| Correspondent | Sagar D Pimpalwar UNITED STATES ENDOSCOPY 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 | 2014-03-27 |
| Decision Date | 2014-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765012823 | K140763 | 000 |
| 10724995182622 | K140763 | 000 |
| 10724995182875 | K140763 | 000 |