The following data is part of a premarket notification filed by Nissha Medical Technologies Sas with the FDA for Endotube.
| Device ID | K203350 |
| 510k Number | K203350 |
| Device Name: | ENDOtube |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | Nissha Medical Technologies SAS ZA Des Boutries 12 Rue Des Cayennes Conflans Ste Honorine, FR 78700 |
| Contact | Roch Mignot |
| Correspondent | Roch Mignot Nissha Medical Technologies SAS ZA Des Boutries 12 Rue Des Cayennes Conflans Ste Honorine, FR 78700 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-13 |
| Decision Date | 2021-09-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENDOTUBE 87944328 not registered Dead/Abandoned |
Graphic Controls Acquisition Corp. 2018-06-01 |