MOBILE OPERATING TABLE FOR ORL MICROSURGERY— 510(k) K853720

Name: FDA 510(k) clearance K853720
Creator: U.S. Food and Drug Administration
Published: 1985-10-18

Substantially Equivalent

Carl Zeiss, Inc.

FDA 510(k) clearance K853720 for MOBILE OPERATING TABLE FOR ORL MICROSURGERY, Substantially Equivalent on 1985-10-18. Applicant: Carl Zeiss, Inc.. Device class: 1.

Clearance details

Applicant: Carl Zeiss, Inc.
Product code: Code GDC
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1985-09-05
Decision date: 1985-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thornwood, NY, US

Download summary PDF View on FDA.gov ↗

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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.