OMNI-TRACT CHEST WALL & LUNA RETRACTOR— 510(k) K853947

Substantially Equivalent

Minnesota Scientific, Inc.

FDA 510(k) clearance K853947 for OMNI-TRACT CHEST WALL & LUNA RETRACTOR, Substantially Equivalent on 1985-10-16. Applicant: Minnesota Scientific, Inc..

Clearance details

Applicant: Minnesota Scientific, Inc.
Product code: Code GAD
Advisory panel: General, Plastic Surgery
Date received: 1985-09-24
Decision date: 1985-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code GAD

product code GAD

Malfunction: 504
Total: 504

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.