Genesis Low Temperature Reusable Rigid Container System
FDA 510(k) K153554 · Carefusion 2200, Inc.
510(k) numberK153554
Submission
- Device name
- Genesis Low Temperature Reusable Rigid Container System
- Applicant
- Carefusion 2200, Inc.
Vernon Hills, IL, US - Received
- December 14, 2015
- Decision date
- March 21, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
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| K142529 | Genesis Reusable Rigid Container SystemKCT · Traditional | 01/08/2015SE |
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Questions and answers
When was Genesis Low Temperature Reusable Rigid Container System cleared by the FDA?
Genesis Low Temperature Reusable Rigid Container System (K153554) received a 510(k) decision of Substantially Equivalent on March 21, 2016, 98 days after the submission was received.
What is the product code of K153554?
The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.