# K992141: Olympus Working Element for Probes

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Sep 29, 1999 after 97 days
- Product code: FDC (Resectoscope, Working Element)
- 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: 1 generation back to K790071 (1979). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K790071: Endoscope and Accessories, Olympus Corp. (1979) Summary page 1.
- K904939: Flexible and Rigid Ureterotome System, Olympus Corp. (1992) Summary page 1.
- (no number) Working element with open handle and probe guide channel Type 8654.281: named in the summary without a submission number
- (no number) Injection cannula flexible, 4.5 Fr Type 8654.951: named in the summary without a submission number

## Most influential descendants
- K050910: Roei Working Element and Roel Cutting Loops (2005), 1 descendant of its own
- K053322: Modification to: Roei Working Element and Roei Cutting Loops (2006), 0 descendants of its own

## Indications for use
The Olympus working element for probes (e.g. laser fibers), guiding tubes and injection cannula are intended to examine and to perform various diagnostic and therapeutic procedures in the urological tract.

Source page: https://510kreport.com/device/K992141
Methodology: https://510kreport.com/methodology