510(k) Report

510(k) · Cleared

Cleared

Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 MM, Accessories

K042523510(k) TraditionalCleared Mar 18, 2005182-day reviewClass II21 CFR 876.1500

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 18, 2005 after a 182-day review. The FDA summary names no predicate by number. 9 later devices descend from it.

Decided
Mar 18, 2005
Review
182 days
Class
Class II
Product code
FJL
Recalls
None
Predicates
0

9 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2019: 4 descendants cleared2018: 1 descendant cleared2017: 1 descendant cleared2007: 1 descendant cleared2025: 1 descendant cleared2023: 1 descendant cleared20052010201520202025
  1. This deviceK042523 Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3…Richard Wolf Medical Instruments Corp. · 2005
  2. Descendant · cites it directly · 7 of its ownK162979 Veloxion SystemCorinth Medtech, Inc. · 2017
  3. Descendant · 2 generations on · 3 of its ownK190099 Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion…Corinth Medtech, Inc. · 2019
  4. Descendant · cites it directly · 2 of its ownK180752 Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device…Corinth Medtech, Inc. · 2018
  5. Descendant · cites it directly · 2 of its ownK062720 S-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp. · 2007 · Recalled
  6. Descendant · cites it directly · 1 of its ownK191341 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion…Corinth Medtech, Inc. · 2019

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2007: 12017: 12018: 12019: 42023: 12025: 1
2007high 4 (2019) · low 0 (2008)2026

Most influential descendants

Showing 5 of 9 · See all
  • K162979Veloxion SystemCorinth Medtech, Inc. · 2017 · cites it directly7descendants
  • K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc. · 2019 · 2 generations on3descendants
  • K180752Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid…Corinth Medtech, Inc. · 2018 · cites it directly2descendants
  • K062720S-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp. · 2007 · cites it directly2descendants
  • K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc. · 2019 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042523Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 MM…Richard Wolf Medical Instruments Corp.2005—
+1K162979Veloxion SystemCorinth Medtech, Inc.2017—
+2K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope…Corinth Medtech, Inc.2019—
+1K180752Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit…Corinth Medtech, Inc.2018—
+1K062720S-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp.20072
+1K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope…Corinth Medtech, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201710
201810
201940
202310
202510
FIG. 1 — Lineage of K042523, 2005–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K221893 KARL STORZ Bipolar Resectoscopes with HF Cablescore 7.1 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (9)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162979Veloxion SystemCorinth Medtech, Inc.20177
K180752Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid…Corinth Medtech, Inc.20182
K062720S-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp.20072
K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion…Corinth Medtech, Inc.20191

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K162979 (Corinth Medtech, Inc., 2017) has gone furthest, with 7 descendants of its own.

How does its category compare?

All FJL devices

FJL Resectoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FJL

1in 2024

2007: 12010: 12017: 12019: 22023: 22024: 1
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

2013: 12022: 1
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

2007: 112008: 112009: 152010: 342011: 182012: 262013: 242014: 362015: 452016: 252017: 282018: 502019: 532020: 552021: 542022: 742023: 742024: 342025: 67
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—011
20080—011
20090—015
20101—034
20110—018
20120—026
20130—124
20140—036
20150—045
20160—025
20171—028
20180—050
20192—053
20200—055
20210—054
20220—174
20232—074
20241—034
20250—067
20260—0—

What is it indicated for?

The Resection Pump 2228 with Resectoscope 8659.xxx is used for endoscopically controlled tissue chip resection and removal of intrauterine poJyps, intrauterine myomas or prostate adenomas via suction channel under continuous flow conditions following resection using a high-frequency electrode with a resectoscope.

Indications for use as stated in the FDA summary.

More from Richard Wolf Medical Instruments Corp.

146 FDA decisions under this applicant name. See the company

  • P870080/S002Hulka Clip for Tubal OcclusionRichard Wolf Medical Instruments Corp. · 2016
  • K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp. · 2016
  • K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
  • K121724Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012
  • K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX Keyport Trocar…Richard Wolf Medical Instruments Corp. · 2012

Recent decisions in FJL

The FJL category page

  • K232486KARL STORZ Monopolar Resectoscopes with HF CableKarl Storz SE & CO. KG · 2024
  • K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc. · 2023
  • K230205Veloxion SystemCorinth Medtech, Inc. · 2023
  • K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit…Corinth Medtech, Inc. · 2019
  • K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit…Corinth Medtech, Inc. · 2019

https://510kreport.com/device/K042523 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042523: Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 MM, Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042523

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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