ENDO-EASE ENDOSCOPIC OVERTUBE— 510(k) K060235

Name: FDA 510(k) clearance K060235
Creator: U.S. Food and Drug Administration
Published: 2006-08-04

Substantially Equivalent

Spirus Medical, Inc.

FDA 510(k) clearance K060235 for ENDO-EASE ENDOSCOPIC OVERTUBE, Substantially Equivalent on 2006-08-04. Applicant: Spirus Medical, Inc.. Device class: 2.

Clearance details

Applicant: Spirus Medical, Inc.
Product code: Code FDA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2006-01-30
Decision date: 2006-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ayer, MA, US

Download summary PDF View on FDA.gov ↗

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K080050 — SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE2008-05-06
K080042 — SPIRUS MEDICAL SURGICAL INSTRUMENT2008-04-03
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Adverse events under product code FDA

product code FDA

Death: 8
Injury: 148
Total: 156

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.