KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT— 510(k) K953980

Name: FDA 510(k) clearance K953980
Creator: U.S. Food and Drug Administration
Published: 1995-11-16

Substantially Equivalent

Kreuzer Corp.

FDA 510(k) clearance K953980 for KREUZER CEILING MOUNTED SUPPORT SYSTEMS, KLINOPORT, Substantially Equivalent on 1995-11-16. Applicant: Kreuzer Corp.. Device class: 1.

Clearance details

Applicant: Kreuzer Corp.
Product code: Code FQO
Device class: Class 1
Regulation: 21 CFR 878.4960
Advisory panel: General, Plastic Surgery
Date received: 1995-08-23
Decision date: 1995-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murfreesboro, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FQO

view all

K240598 — Maestro System (REF100)2024-06-03
K221410 — Maestro Platform2022-12-02
K090136 — STERIS CMAX XLT SURGICAL TABLE2009-03-20
K972810 — OPT80 THE TRANSPORTABLE (OPT80)1997-08-26
K971988 — ALLEN, ULTRA AND SMART SOCKETS1997-07-11

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.