# K980592: Ntech Cystoscopes

- Pathway: 510(k) (Traditional)
- Applicant: N-Tech Endoscopy, Inc.
- Decided: Apr 28, 1998 after 70 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
Our Cystoscopes are used when Operative and/or Diagnostic Cystoscopy is medically indicated, Cystoscopes are used for 2 tasks: Providing an excellent visual image and good illumination of the operating area.

Source page: https://510kreport.com/device/K980592
Methodology: https://510kreport.com/methodology