510(k) Report

510(k) · Cleared

Recalled · 2008

Vanguard Reprocessed Arthroscopic Wands

K043198510(k) TraditionalCleared May 27, 2005190-day reviewClass II21 CFR 878.4400Recalls 1

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

Vanguard Medical Concepts, Inc. · NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Cleared on May 27, 2005 after a 190-day review. The FDA summary names no predicate by number. 1 later device descends from it. It has been recalled once.

Decided
May 27, 2005
Review
190 days
Class
Class II
Product code
NUJ
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared20052010201520202025
  1. This deviceK043198 Vanguard Reprocessed Arthroscopic WandsVanguard Medical Concepts, Inc. · 2005
  2. Descendant · cites it directly · 0 of its ownK052692 Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K043198Vanguard Reprocessed Arthroscopic WandsVanguard Medical Concepts, Inc.2005—
+1K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K043198, 2005–2006Source: 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 NUJ? 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 NUJ device

  1. #1 K220411 Reprocessed LigaSure Curved, Small Jaw, Open…score 8.4 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K052692Suretek Medical Reprocessed Electrosurgical ElectrodesSuretek Medical20060

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 11, 2008Not classifiedZ-1669-2008Process controlSterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K052692 (Suretek Medical, 2006) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NUJ devices

NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NUJ

1in 2024

2008: 12010: 12011: 22012: 22013: 22014: 12015: 22016: 52017: 32018: 72019: 12022: 22023: 12024: 1
2007high 7 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NUJ

88in 2018

2016: 155 days median2017: 49 days median2018: 88 days median
2007high 155 (2016) · low 49 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NUJ

11in 2025

2008: 22023: 32025: 11
2007high 11 (2025) · low 0 (2007)2026

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

Adverse event reports per year · NUJ

38in 2025

2007: 42008: 42009: 12010: 92011: 22012: 392013: 1612014: 742015: 252016: 522017: 512018: 142019: 202020: 592021: 472022: 312023: 272024: 922025: 38
2007high 161 (2013) · low 1 (2009)2025

MAUDE reports naming product code NUJ, 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
20070—04
20081—24
20090—01
20101—09
20112—02
20122—039
20132—0161
20141—074
20152—025
20165155052
2017349051
2018788014
20191—020
20200—059
20210—047
20222—031
20231—327
20241—092
20250—1138
20260—0—

What is it indicated for?

When coupled with a compatible electrosurgical unit, an arthroscopic wand electrode is intended for resection, ablation and coagulation of soft tissues and for hemostasis of blood vessels during arthroscopic procedures (of the knee, shoulder, ankle, elbow, and wrist) that utilize a conductive irrigant.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K043198: Vanguard Reprocessed Arthroscopic Wands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043198

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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