STERILE EQUIPMENT COVERS— 510(k) K052395

Clearance details

Applicant

Volcano Corporation

Product code

Code KKX

Device class

Class 2

Regulation

21 CFR 878.4370

Advisory panel

General, Plastic Surgery

Date received

2005-08-31

Decision date

2005-12-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rancho Cordova,, CA, US

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• Z-1041-2016 — Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.Class II·Terminated·Volcano Corporation·20160205
• Z-1042-2016 — Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.Class II·Terminated·Volcano Corporation·20160205

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052395.