510(k) · Cleared

Recalled · Class II · 2021

S-Line Bipolar Resectoscopes and Bipolar Electrodes

K062720510(k) TraditionalCleared Mar 22, 2007191-day reviewClass II21 CFR 876.1500Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Richard Wolf Medical Instruments Corp. · FJL Resectoscope

Cleared on Mar 22, 2007 as substantially equivalent to K980302 (Richard Wolf Medical Instruments Corp., 1998) and 3 other predicates after a 191-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it. It has been recalled 2 times.

Decided: Mar 22, 2007
Review: 191 days
Class: Class II
Product code: FJL
Recalls: 2
Predicates: 4

Its longest line of descent runs back 3 generations to K951972 (1995). 10 ancestors in all, the oldest K890328 (1990). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK951972 Cabot Medical Ultra Flow Cystourethroscope System with Operating &…Cabot Medical Corp. · 1995
2 generations backK021166 Acmi Bipolar Rectoscope, Model Eiwe-BRAcmi-Circon Corporation · 2002
1 generation backK031001 Acmi Vista CTR Bipolar Loop ElectrodeAcmi Corporation · 2003
This deviceK062720 S-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp. · 2007
Descendant · cites it directly · 1 of its ownK191341 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion…Corinth Medtech, Inc. · 2019
Descendant · 2 generations on · 0 of its ownK250522 Multi4 SystemMulti4 Medical AB · 2025

Most influential descendants

Showing 2 of 2 · See all

K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc. · 2019 · cites it directly1descendant
K250522Multi4 SystemMulti4 Medical AB · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K951972	Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic…	Cabot Medical Corp.	1995	—
−2	K021166	Acmi Bipolar Rectoscope, Model Eiwe-BR	Acmi-Circon Corporation	2002	—
−1	K031001	Acmi Vista CTR Bipolar Loop Electrode	Acmi Corporation	2003	—
0 (this device)	K062720	S-Line Bipolar Resectoscopes and Bipolar Electrodes	Richard Wolf Medical Instruments Corp.	2007	—
+1	K191341	Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope…	Corinth Medtech, Inc.	2019	—
+2	K250522	Multi4 System	Multi4 Medical AB	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	2	0
1996	1	0
1998	2	0
2002	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2025	1	0

FIG. 1 — Lineage of K062720, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FJL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FJL device

#1 K221893 KARL STORZ Bipolar Resectoscopes with HF Cablescore 7.1 · 8 generations · no Class I recall
#2 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K980302	Working Elements, Resectoscope Sheaths, Electrodes, Obturators, Endoscopes Summary page 1 …rmation on devica to Wicsbstaialu e ic 510(k) Number- Trade or propietary or model name Manufacturer 1 K980302 I Resectoscopes E-line 1 Richard Wolf 2 K042523 2 Resection Pump and Resectoscope for Chip 2…	Richard Wolf Medical Instruments Corp.	1998	1
*	K042523	Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 MM, Accessories Summary page 1 …er- Trade or propietary or model name Manufacturer 1 K980302 I Resectoscopes E-line 1 Richard Wolf 2 K042523 2 Resection Pump and Resectoscope for Chip 2 Richard Wolf Aspiraijon (Resection Master) 3. Not known…	Richard Wolf Medical Instruments Corp.	2005	—
*	K031001	Acmi Vista CTR Bipolar Loop Electrode Summary page 1 …mp and Resectoscope for Chip 2 Richard Wolf Aspiraijon (Resection Master) 3. Not known 3. Bipolar resectoscope 3. Olympus 4 K031001 4 ACMI Vista CTR Bipolar Loop Electrode 4 ACMI 5 K022480 5ACMI Disposable Bipolar Cord 5 ACMI 6…	Acmi Corporation	2003	—
*	K022480	Acmi Disposable Bipolar Cord, Model DBC Summary page 1 …raijon (Resection Master) 3. Not known 3. Bipolar resectoscope 3. Olympus 4 K031001 4 ACMI Vista CTR Bipolar Loop Electrode 4 ACMI 5 K022480 5ACMI Disposable Bipolar Cord 5 ACMI 6Notknown 6PlasmaKinetic TissueManagementSystem 6Gru…	Acmi Corporation	2002	—
*	—	Bipolar resectoscope (Olympus) Named without a submission number			—
*	—	PlasmaKinetic Tissue Management System (Gyrus) Named without a submission number			—

Also cleared against K980302: 3 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K191341	Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…	Corinth Medtech, Inc.	2019	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 25, 2021	Class II	Z-2246-2021	Under Investigation by firm	Product labeled as Cutting Electrode may contain BIVAP electrode.
Sep 18, 2013	Class II	Z-0145-2014	Process control	Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
2 of the 10 ancestors have a recall of any class.
Of its descendants, K191341 (Corinth Medtech, Inc., 2019) has gone furthest, with 1 descendant of its own.
3 other devices also cite its predicate K980302.

How does its category compare?

All FJL devices

FJL Resectoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FJL

1in 2024

2007high 2 (2019) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FJL

Too few FJL 510(k)s in any year since 2007 to give a median.

Recalls per year · FJL

1in 2022

2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FJL

67in 2025

2007high 74 (2022) · low 11 (2007)2025

MAUDE reports naming product code FJL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	11
2008	0	—	0	11
2009	0	—	0	15
2010	1	—	0	34
2011	0	—	0	18
2012	0	—	0	26
2013	0	—	1	24
2014	0	—	0	36
2015	0	—	0	45
2016	0	—	0	25
2017	1	—	0	28
2018	0	—	0	50
2019	2	—	0	53
2020	0	—	0	55
2021	0	—	0	54
2022	0	—	1	74
2023	2	—	0	74
2024	1	—	0	34
2025	0	—	0	67
2026	0	—	0	—

What is it indicated for?

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.…

Read the full statement (113 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062720 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062720: S-Line Bipolar Resectoscopes and Bipolar Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062720

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026