The following data is part of a premarket notification filed by Era Endoscopy S.r.l. with the FDA for Endotics.
| Device ID | K190669 |
| 510k Number | K190669 |
| Device Name: | Endotics |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | Era Endoscopy S.r.l. Via Boccioni, 1 Peccioli, IT 56037 |
| Contact | Alberto Arena |
| Correspondent | Alberto Arena Era Endoscopy S.r.l. Via Boccioni, 1 Peccioli, IT 56037 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-15 |
| Decision Date | 2020-01-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ENDOTICS 88361354 not registered Live/Pending |
Era Endoscopy S.r.l. 2019-03-28 |
![]() ENDOTICS 79110712 4232032 Dead/Cancelled |
Era Endoscopy S.r.l. 2012-01-18 |