# K962506: [Specialized Tissue Aspirating Resectoscope (Star)]

- Pathway: 510(k) (Traditional)
- Applicant: Gynecare Innovation Center
- Decided: Sep 16, 1996 after 81 days
- Product code: FJL (Resectoscope)
- 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) FemRx STAR System: named in the summary without a submission number

## Indications for use
The FemRx STAR System is intended for urological transurethral resection by trained professional urologists in hospital environments. This device is intended for resection, morcellation and aspiration of tissue in the urethra, prostate and bladder.

Source page: https://510kreport.com/device/K962506
Methodology: https://510kreport.com/methodology