# K053322: Modification to: Roei Working Element and Roei Cutting Loops

- Pathway: 510(k) (Special)
- Applicant: Roei Medical Technologies, Ltd.
- Decided: Jan 6, 2006 after 37 days
- Product code: FAS (Electrode, Electrosurgical, Active, Urological)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K903323 (1990). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050910: Roei Working Element and Roel Cutting Loops, Roei Medical Technologies, Ltd. (2005) Summary page 1.

## Indications for use
The Roei Working Element and Roei Cutting Loops are device accessories intended for use with monopolar resectoscope systems for the resection of soft tissue and are indicated for use in transuretheral bladder tumor resection (TURBT), transurethral prostatic and bladder biopsy, and transurethral resection of the prostate (TURP).

Source page: https://510kreport.com/device/K053322
Methodology: https://510kreport.com/methodology