GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER— 510(k) K874690

Substantially Equivalent

Mentor Corp.

FDA 510(k) clearance K874690 for GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER, Substantially Equivalent on 1988-02-08. Applicant: Mentor Corp..

Clearance details

Applicant: Mentor Corp.
Product code: Code FFX
Advisory panel: Gastroenterology, Urology
Date received: 1987-11-16
Decision date: 1988-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

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.