REDTECH GIPC 2000— 510(k) K004040

Substantially Equivalent

Red-Tech, Inc.

FDA 510(k) clearance K004040 for REDTECH GIPC 2000, Substantially Equivalent on 2001-03-29. Applicant: Red-Tech, Inc..

Clearance details

Applicant: Red-Tech, Inc.
Product code: Code FFX
Advisory panel: Gastroenterology, Urology
Date received: 2000-12-29
Decision date: 2001-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

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Adverse events under product code FFX

product code FFX

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.