# K201617: TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))

- Pathway: 510(k) (Traditional)
- Applicant: Schoelly Fiberoptic GmbH
- Decided: Mar 12, 2021 after 270 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931154 (1993). 32 ancestors in all.
No later device cites it as a predicate yet.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111788: Endoeye HD II, Olympus America, Inc. (2012) Summary page 4.
- K111425: Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190, Olympus Medical Systems Corp. (2012) Summary page 5.

## Indications for use
The TipVision 0º/30º Videoscopes and EleVision HD 2 CCU are indicated for visualization during general laparoscopy, gynecological laparoscopy, urological laparoscopy, and video-assisted minimally invasive thoracic procedures.

Source page: https://510kreport.com/device/K201617
Methodology: https://510kreport.com/methodology