SKYTRON ELITE 6000 & 6001 SURGICAL TABLES— 510(k) K853480

Substantially Equivalent

Skytron, Div. the Kmw Group, Inc.

FDA 510(k) clearance K853480 for SKYTRON ELITE 6000 & 6001 SURGICAL TABLES, Substantially Equivalent on 1985-09-12. 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: 1985-08-20
Decision date: 1985-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

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.