VARICES INJECTION NEEDLE— 510(k) K012977

Substantially Equivalent

Endo-Therapeutics, Inc.

FDA 510(k) clearance K012977 for VARICES INJECTION NEEDLE, Substantially Equivalent on 2001-11-02. Applicant: Endo-Therapeutics, Inc..

Clearance details

Applicant: Endo-Therapeutics, Inc.
Product code: Code FBK
Advisory panel: Gastroenterology, Urology
Date received: 2001-09-05
Decision date: 2001-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Safety Harbor, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

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.