ENDO-TECH LTD., TIPS— 510(k) K961695

Substantially Equivalent

Ratio Design Lab

FDA 510(k) clearance K961695 for ENDO-TECH LTD., TIPS, Substantially Equivalent on 1996-07-01. Applicant: Ratio Design Lab.

Clearance details

Applicant: Ratio Design Lab
Product code: Code HFG
Advisory panel: Obstetrics/Gynecology
Date received: 1996-05-01
Decision date: 1996-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alpheretta, GA, US

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Adverse events under product code HFG

product code HFG

Death: 3
Injury: 121
Total: 124

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.