# K111480: Maxiflex - Semi Flex Scope, 25 to 65 CM

- Pathway: 510(k) (Traditional)
- Applicant: Technology Delivery Systems, Inc.
- Decided: Apr 4, 2012 after 313 days
- Product code: FGB (Ureteroscope And Accessories, Flexible/Rigid)
- 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: 2 generations back to K971977 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062725: Maxiflex-Semi Flex Scope, Technology Delivery Systems, Inc. (2006) Summary page 1.
- K023358: Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8, Acmi Corporation (2003) Summary page 1.

## Indications for use
The MaxiFlex Semi Flex Scopes are intended to be used by trained medical professionals to examine the urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. Device may be re-used and re-sterilized by the EtO sterilization process up to 3 times

Source page: https://510kreport.com/device/K111480
Methodology: https://510kreport.com/methodology