STILLE SCANDIA OPERATING TABLES RC 3000,1100— 510(k) K850168

Name: FDA 510(k) clearance K850168
Creator: U.S. Food and Drug Administration
Published: 1985-03-28

Substantially Equivalent

Stille-Werner (Usa), Inc.

FDA 510(k) clearance K850168 for STILLE SCANDIA OPERATING TABLES RC 3000,1100, Substantially Equivalent on 1985-03-28. Applicant: Stille-Werner (Usa), Inc.. Device class: 1.

Clearance details

Applicant: Stille-Werner (Usa), Inc.
Product code: Code GDC
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1985-01-16
Decision date: 1985-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ronkonkoma, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDC

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K971390 — QUANTUM 3080SP SURGICAL TABLE1997-05-15
K970807 — MOBILE OPERATING TABLE 1132.011997-03-14
K964273 — DURA-BOARD ARMBOARD1997-01-08
K940616 — SKYTRON ELITE 3500 TABLE1994-06-13
K934744 — MIDMARK MAGNUM GENERAL SURGICAL TABLE1994-03-28

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.