CONMED INTEGRATED SYSTEMS NURSES ASSISTANT— 510(k) K031979

Name: FDA 510(k) clearance K031979
Creator: U.S. Food and Drug Administration
Published: 2003-07-25

Substantially Equivalent

Conmed Integrated Systems (Cmis)

FDA 510(k) clearance K031979 for CONMED INTEGRATED SYSTEMS NURSES ASSISTANT, Substantially Equivalent on 2003-07-25. Applicant: Conmed Integrated Systems (Cmis). Device class: 2.

Clearance details

Applicant: Conmed Integrated Systems (Cmis)
Product code: Code FSY
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2003-06-26
Decision date: 2003-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Beaverton, OR, US

Download summary PDF View on FDA.gov ↗

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K052740 — NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM2005-10-17
K050829 — NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM2005-05-06

Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

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.