The following data is part of a premarket notification filed by Schoelly Fiberoptic Gmbh with the FDA for Tipvision Videoscope System (tipvision Videoscope 0°/30°; Elevision Hd 2 Camera Control Unit (ccu)).
| Device ID | K201617 |
| 510k Number | K201617 |
| Device Name: | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | Schoelly Fiberoptic GmbH Robert-Bosch-Strasse 1-3 Denzlingen, DE 79211 |
| Contact | Sandra Baumann |
| Correspondent | Pamela Papineau Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432 |
| Product Code | HET |
| Subsequent Product Code | FET |
| Subsequent Product Code | GCJ |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-15 |
| Decision Date | 2021-03-12 |