# K062720: S-Line Bipolar Resectoscopes and Bipolar Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Mar 22, 2007 after 191 days
- Product code: FJL (Resectoscope)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K951972 (1995). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980302: Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes, Richard Wolf Medical Instruments Corp. (1998) Summary page 1.
- K042523: Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 MM, Accessories, Richard Wolf Medical Instruments Corp. (2005) Summary page 1.
- K031001: Acmi Vista CTR Bipolar Loop Electrode, Acmi Corporation (2003) Summary page 1.
- K022480: Acmi Disposable Bipolar Cord, Model DBC, Acmi Corporation (2002) Summary page 1.
- (no number) Bipolar resectoscope (Olympus): named in the summary without a submission number
- (no number) PlasmaKinetic Tissue Management System (Gyrus): named in the summary without a submission number

## Most influential descendants
- K191341: Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (2019), 1 descendant of its own
- K250522: Multi4 System (2025), 0 descendants of its own

## Recalls of this device
- Jun 25, 2021 · Class II · Z-2246-2021: Product labeled as Cutting Electrode may contain BIVAP electrode.
- Sep 18, 2013 · Class II · Z-0145-2014: Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.

## Indications for use
S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCI solution (saline) as the irrigation medium. For Urology: Urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. Transurethral resection of the prostate (TURP) and bladder neck. Transurethral resection of the bladder tumors (TURBT). Transurethral incision of the prostate. Coagulation of bleeding in the lower urinary tract. For Gynecology: Tissue cutting, removal, and desiccation as required or encountered in gynecologic hystroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation. Excision of intrauterine myomas. Excision of intrauterine polyps. Lysis of intrauterine septa. Endometrial ablation.

Source page: https://510kreport.com/device/K062720
Methodology: https://510kreport.com/methodology