510(k) · Cleared

Cleared

Smith & Nephew Vascular Videoendoscope System, Model 7209273

K012724510(k) TraditionalCleared Nov 8, 200186-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

Cleared on Nov 8, 2001 as substantially equivalent to K963184 (Olympus America, Inc., 1996) and 2 other predicates after an 86-day review. Its family tree reaches back 2 generations to 1995.

Decided: Nov 8, 2001
Review: 86 days
Class: Class II
Product code: LYK
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K950076 (1995). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK950076 LaparoscopeOlympus America, Inc. · 1995
1 generation backK963184 Olympus Subcutaneous Endoscopy SystemOlympus America, Inc. · 1996
This deviceK012724 Smith & Nephew Vascular Videoendoscope System, Model 7209273Smith & Nephew, Inc. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K950076	Laparoscope	Olympus America, Inc.	1995	—
−1	K963184	Olympus Subcutaneous Endoscopy System	Olympus America, Inc.	1996	—
0 (this device)	K012724	Smith & Nephew Vascular Videoendoscope System, Model 7209273	Smith & Nephew, Inc.	2001	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1997	2	0

FIG. 1 — Lineage of K012724, 1995–2001Source: 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 LYK? 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 LYK device

#1 K253842 Vena MicroAngioscope™ Systemscore 10.8 · 1 generation · no Class I recall
#2 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

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
*	K963184	Olympus Subcutaneous Endoscopy System Summary page 4 …VideoEndoscope Common Name: Vascular Endoscope Classification Name: Endoscope and/or Accessories D. Predicate Devices Olympus Endoscopic System for Vessel Harvesting K963184 Ethicon’s EndoPath Ultra Retractor and Vessel Dissector K973139 Smith & Nephew’s Images Endoscopes K971850 E. Description of Dev…	Olympus America, Inc.	1996	—
*	K973139	Endopath Ultra-Retractor/ Endopath Vessel Dissector Summary page 4 …Name: Endoscope and/or Accessories D. Predicate Devices Olympus Endoscopic System for Vessel Harvesting K963184 Ethicon’s EndoPath Ultra Retractor and Vessel Dissector K973139 Smith & Nephew’s Images Endoscopes K971850 E. Description of Device The proposed Smith & Nephew Vascular VideoEndoscope is desi…	Ethicon Endo-Surgery, Inc.	1997	—
*	K971850	Smith & Nephew Images Endoscopes and Accessories Summary page 4 …icate Devices Olympus Endoscopic System for Vessel Harvesting K963184 Ethicon’s EndoPath Ultra Retractor and Vessel Dissector K973139 Smith & Nephew’s Images Endoscopes K971850 E. Description of Device The proposed Smith & Nephew Vascular VideoEndoscope is designed in an “L” shaped configuration as to h…	Smith & Nephew, Inc.	1997	—

Also cleared against K963184: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
None of the 6 ancestors has a recall.
2 other devices also cite its predicate K963184.

How does its category compare?

All LYK devices

LYK Angioscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYK

1in 2025

2007high 1 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYK

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

Recalls per year · LYK

No recall names LYK since 2007.

Adverse event reports per year · LYK

1in 2024

2007high 2 (2013) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	1
2011	0	—	0
2012	0	—	0
2013	0	—	2
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	1
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	1
2025	1	—	0
2026	1	—	—

What is it indicated for?

The Smith & Nephew Vascular VideoEndoscope is indicated for use in subcutanous endoscopy,

specifically for endocopically gaining access to, ligating and/or harvesting vessels within the

subcutaneous and subfascial surgical planes in the lower extremities.

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

https://510kreport.com/device/K012724 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012724: Smith & Nephew Vascular Videoendoscope System, Model 7209273.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012724

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026