SURGICAL COLDLIGHT, AX8— 510(k) K770861

Substantially Equivalent

Affiliated Hospital Products, Inc.

FDA 510(k) clearance K770861 for SURGICAL COLDLIGHT, AX8, Substantially Equivalent on 1977-06-17. Applicant: Affiliated Hospital Products, Inc..

Clearance details

Applicant: Affiliated Hospital Products, Inc.
Product code: Code FTD
Advisory panel: General, Plastic Surgery
Date received: 1977-05-09
Decision date: 1977-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FTD

product code FTD

Malfunction: 767
Total: 767

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.