The following data is part of a premarket notification filed by C2 Therapeutics with the FDA for Sidecar External Working Channel.
| Device ID | K150083 |
| 510k Number | K150083 |
| Device Name: | Sidecar External Working Channel |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | C2 THERAPEUTICS 303 CONVENTION WAY SUITE 1 Redwood City, CA 94063 |
| Contact | Theresa Brandner-allen |
| Correspondent | Theresa Brandner-allen C2 THERAPEUTICS 303 CONVENTION WAY SUITE 1 Redwood City, CA 94063 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-15 |
| Decision Date | 2015-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854924006118 | K150083 | 000 |