The following data is part of a premarket notification filed by Trokamed Gmbh with the FDA for Mini Pcnl-system.
| Device ID | K200770 |
| 510k Number | K200770 |
| Device Name: | Mini PCNL-System |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | Trokamed GmbH Kleine Breite 17 Geisingen, DE 78187 |
| Contact | Stefan Weiland |
| Correspondent | Stefan Weiland Trokamed GmbH Kleine Breite 17 Geisingen, DE 78187 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-25 |
| Decision Date | 2021-07-30 |