# K050910: Roei Working Element and Roel Cutting Loops

- Pathway: 510(k) (Traditional)
- Applicant: Roei Medical Technologies, Ltd.
- Decided: Jun 16, 2005 after 66 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: 3 generations back to K903323 (1990). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954050: Resectoscopes, KARL STORZ Endoscopy-America, Inc. (1995) Summary page 2.
- K980302: Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes, Richard Wolf Medical Instruments Corp. (1998) Summary page 2.
- K951972: Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic Sheaths, Cabot Medical Corp. (1995) Summary page 2.
- K992141: Olympus Working Element for Probes, Olympus Winter & Ibe GmbH (1999) Summary page 2.
- K991314: Coaguloop, American Medical Systems, Inc. (1999) Summary page 2.
- K971512: Ams Coaguloop Resection Electrode, American Medical Systems, Inc. (1997) Summary page 2.
- K973820: Usa Elite System Vaportrode Vaporization Electrode and Vaportome Resection Electrode, Circon Corp. (1998) Summary page 2.
- K961706: P1R Plasma Treatment Set for Use in Plasmapheresis with the Fresenius AS104 Cell Separator, Fresenius USA, Inc. (1996) Summary page 2.

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

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

Source page: https://510kreport.com/device/K050910
Methodology: https://510kreport.com/methodology