SKYTRON ELITE 7000 MICRO-SURGERY TABLE— 510(k) K851830

Substantially Equivalent

Skytron, Div. the Kmw Group, Inc.

FDA 510(k) clearance K851830 for SKYTRON ELITE 7000 MICRO-SURGERY TABLE, Substantially Equivalent on 1985-05-17. Applicant: Skytron, Div. the Kmw Group, Inc..

Clearance details

Applicant: Skytron, Div. the Kmw Group, Inc.
Product code: Code GDC
Advisory panel: General, Plastic Surgery
Date received: 1985-04-26
Decision date: 1985-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

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Adverse events under product code GDC

product code GDC

Malfunction: 791
Total: 791

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.