The following data is part of a premarket notification filed by Baronova, Inc. with the FDA for Baronova Retrieval Kit, Baronova Overtube, Baronova Endoscope Cap.
| Device ID | K172575 |
| 510k Number | K172575 |
| Device Name: | BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | BAROnova, Inc. 1509 Industrial Road San Carlos, CA 94070 |
| Contact | Lian Cunningham |
| Correspondent | Lian Cunningham BAROnova, Inc. 1509 Industrial Road San Carlos, CA 94070 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-28 |
| Decision Date | 2018-01-18 |
| Summary: | summary |