# K183264: Flex-THOR scope

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Jan 18, 2019 after 56 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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
Longest line of descent: 4 generations back to K923982 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100533: Vista Endoscope,89 CM, 56CM , Scout Blunt-Tipped Guide- 106 CM, 86 CM, 53 CM, Models FG0027, FG0031, FG0029, FG 0028,, Vibrynt, Inc. (2011) Summary page 4.

## Indications for use
The Flex-THOR System is indicated for use in providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures.

Source page: https://510kreport.com/device/K183264
Methodology: https://510kreport.com/methodology