Sterrad Sterilizer Cyclesure Test Pack
FDA 510(k) K051643 · Advanced Sterilization Products
510(k) numberK051643
Submission
- Device name
- Sterrad Sterilizer Cyclesure Test Pack
- Applicant
- Advanced Sterilization Products
Irvin, CA, US - Received
- June 20, 2005
- Decision date
- August 19, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
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| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 3M Company | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 3M Company | 10/18/2024SE |
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| K162007 | STERRAD NX SterilizerMLR · Special | 02/16/2017SE |
| K160818 | STERRAD® NX Sterilizer with ALLClear TechnologyMLR · Traditional | 09/27/2016SE |
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Questions and answers
When was Sterrad Sterilizer Cyclesure Test Pack cleared by the FDA?
Sterrad Sterilizer Cyclesure Test Pack (K051643) received a 510(k) decision of Substantially Equivalent on August 19, 2005, 60 days after the submission was received.
What is the product code of K051643?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.