S.C.O.R.E.S. UNIT— 510(k) K110898

Name: FDA 510(k) clearance K110898
Creator: U.S. Food and Drug Administration
Published: 2012-07-26

Substantially Equivalent

Ammed Surgical Equipment, LLC

FDA 510(k) clearance K110898 for S.C.O.R.E.S. UNIT, Substantially Equivalent on 2012-07-26. Applicant: Ammed Surgical Equipment, LLC. Device class: 2.

Clearance details

Applicant: Ammed Surgical Equipment, LLC
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2011-03-30
Decision date: 2012-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K110898

K-number listed on FDA's recall record

Z-1266-2016 — The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)Class II·Terminated·PMBS, LLC·20160113

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110898.

Data sourced from openFDA. This site is unofficial and independent of the FDA.