SURGICAL COLDLIGHT, AX8— 510(k) K770861

Name: FDA 510(k) clearance K770861
Creator: U.S. Food and Drug Administration
Published: 1977-06-17

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.. Device class: 2.

Clearance details

Applicant: Affiliated Hospital Products, Inc.
Product code: Code FTD
Device class: Class 2
Regulation: 21 CFR 878.4580
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

Download summary PDF View on FDA.gov ↗

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K771942 — TILT 10, CATALOG #S-26001977-10-27

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.