# K992483: Medifix Inc.

- Pathway: 510(k) (Traditional)
- Applicant: Medifix, Inc.
- Decided: Aug 30, 1999 after 35 days
- Product code: FAJ (Cystoscope 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
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. The FDA summary names its predicate without a number.
- (no number) R. Wolf Cystoscopes: named in the summary without a submission number

## Indications for use
Operative and Diagnostic Cystoscopy for visual imaging and light transmission.

Source page: https://510kreport.com/device/K992483
Methodology: https://510kreport.com/methodology