DERMASPANDERE— 510(k) K860925

Substantially Equivalent

Mri Ventures, Inc.

FDA 510(k) clearance K860925 for DERMASPANDERE, Substantially Equivalent on 1986-03-28. Applicant: Mri Ventures, Inc..

Clearance details

Applicant: Mri Ventures, Inc.
Product code: Code GFD
Advisory panel: General, Plastic Surgery
Date received: 1986-03-11
Decision date: 1986-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MO, US

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Adverse events under product code GFD

product code GFD

Injury: 544
Malfunction: 3,575
Other: 1
Total: 4,120

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.