# K991426: Mahe Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Mahe Intl., Inc.
- Decided: Aug 5, 1999 after 104 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
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) Karl Storz: named in the summary without a submission number
- (no number) Wolf: named in the summary without a submission number

## Indications for use
THE INTENDED USE FOR THE RESECTOSCOPE AND WORKING ELEMENTS IS IN UROLOGICAL PROCEDURES TO ENDOSCOPICALLY REMOVE, CUT, COAGULATE, AND OR TRANSECT TISSUE IN THE BLADDER, PROSTRATE, AND URETHRA. THE SURGEON PERFORMS THE EXAMINATION THROUGH THE URETHRA. THE DOCTOR CONTROLS THE BACK AND FORTH MOVEMENT OF THE ELECTRODE USING FINGER CONTROLS. THE WORKING ELEMENTS ALSO HOUSE A CYSTOSCOPE FOR VISALIZATION. THE HIGH FREQUENCY CABLE TRANSMITS ELECTRICAL CURRENT

Source page: https://510kreport.com/device/K991426
Methodology: https://510kreport.com/methodology