The following data is part of a premarket notification filed by Neptune Medical, Inc. with the FDA for Pathfinder Endoscope Overtube.
| Device ID | K211301 |
| 510k Number | K211301 |
| Device Name: | Pathfinder Endoscope Overtube |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | Neptune Medical, Inc. 1828 El Camino Real Burlingame, CA 94010 |
| Contact | Alex Tilson |
| Correspondent | Ian Broome AlvaMed, Inc. 935 Great Plain Ave, Ste 166 Needham, MA 02492 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-29 |
| Decision Date | 2021-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850006222117 | K211301 | 000 |
| 00850006222100 | K211301 | 000 |
| 00850006222094 | K211301 | 000 |
| 00850006222087 | K211301 | 000 |
| 00850006222070 | K211301 | 000 |
| 00850006222063 | K211301 | 000 |
| 00850006222056 | K211301 | 000 |
| 00850006222049 | K211301 | 000 |