Visura Technologies TEECAD System— 510(k) K180911

Name: FDA 510(k) clearance K180911
Creator: U.S. Food and Drug Administration
Published: 2018-06-20

Substantially Equivalent

Visura Technologies, LLC

FDA 510(k) clearance K180911 for Visura Technologies TEECAD System, Substantially Equivalent on 2018-06-20. Applicant: Visura Technologies, LLC. Device class: 2.

Clearance details

Applicant: Visura Technologies, LLC
Product code: Code FDS
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2018-04-06
Decision date: 2018-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Evanston, IL, US

Download summary PDF View on FDA.gov ↗

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K253702 — Intuitive Endoluminal Gastrointestinal System (IG1000)2026-08-07
K260573 — EvoEndo Single-Use Endoscopy System2026-04-21

Adverse events under product code FDS

product code FDS

Death: 37
Injury: 863
Malfunction: 56,442
Other: 1
Total: 57,343

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.