The following data is part of a premarket notification filed by Evoendo Inc with the FDA for Evoendo Single-use Endoscopy System.
| Device ID | K213606 |
| 510k Number | K213606 |
| Device Name: | EvoEndo Single-Use Endoscopy System |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | EvoEndo Inc 12649 East Caley Ave, Suite 116 Centennial, CO 80111 |
| Contact | Heather Underwood |
| Correspondent | Isabella Schmitt Proxima Clinical Research 2450 Holcombe Boulevard Houston, TX 77021 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-15 |
| Decision Date | 2022-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850031897038 | K213606 | 000 |
| 00850031897021 | K213606 | 000 |
| 00850031897014 | K213606 | 000 |