# K992362: Flexiscope IQ 101

- Pathway: 510(k) (Traditional)
- Applicant: Schoelly Fiberoptic GmbH
- Decided: Aug 5, 1999 after 21 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Scholly Flexiscope IQ 101 is indicated for video visualization and recording of optical images of internal sites in conjunction with endoscopic devices.

Source page: https://510kreport.com/device/K992362
Methodology: https://510kreport.com/methodology