AMSCO SURGICAL TABLE— 510(k) K971307

Name: FDA 510(k) clearance K971307
Creator: U.S. Food and Drug Administration
Published: 1997-06-27

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K971307 for AMSCO SURGICAL TABLE, Substantially Equivalent on 1997-06-27. Applicant: STERIS Corporation. Device class: 1.

Clearance details

Applicant: STERIS Corporation
Product code: Code FQO
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1997-04-08
Decision date: 1997-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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K972810 — OPT80 THE TRANSPORTABLE (OPT80)1997-08-26
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Adverse events under product code FQO

product code FQO

Death: 6
Injury: 145
Malfunction: 685
Total: 836

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.