STERRAD 50 & STERRAD 100S STERILIZERS— 510(k) K023290

Clearance details

Applicant

Advanced Sterilization Products

Product code

Code FLF

Device class

Class 2

Regulation

21 CFR 880.6860

Advisory panel

General Hospital

Date received

2002-10-02

Decision date

2003-04-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irvin, CA, US

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• Z-0842-2015 — STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.Class II·Terminated·Advanced Sterilization Products·20141104
• Z-0843-2015 — STERRAD 100S, Product Code 10113. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.Class II·Terminated·Advanced Sterilization Products·20141104
• Z-0744-2014 — STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments.Class II·Terminated·Advanced Sterilization Products·20131216
• Z-0745-2014 — STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 50 process to inactivate microorganisms on a broad range of medical devices and surgical instruments.Class II·Terminated·Advanced Sterilization Products·20131216
• Z-0746-2014 — STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100S process to inactivate microorganisms on a broad range of medical devices and surgical instruments.Class II·Terminated·Advanced Sterilization Products·20131216

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023290.