Sidecar External Working Channel— 510(k) K150083

Name: FDA 510(k) clearance K150083
Creator: U.S. Food and Drug Administration
Published: 2015-04-14

Substantially Equivalent

C2 Therapeutics

FDA 510(k) clearance K150083 for Sidecar External Working Channel, Substantially Equivalent on 2015-04-14. Applicant: C2 Therapeutics. Device class: 2.

Clearance details

Applicant: C2 Therapeutics
Product code: Code FED
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2015-01-15
Decision date: 2015-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood, Ca, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.