Myosure Intrument Tray
FDA 510(k) K121280 · Hologic, Inc.
510(k) numberK121280
Submission
- Device name
- Myosure Intrument Tray
- Applicant
- Hologic, Inc.
Malborough, MA, US - Received
- April 30, 2012
- Decision date
- February 8, 2013
- 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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Questions and answers
When was Myosure Intrument Tray cleared by the FDA?
Myosure Intrument Tray (K121280) received a 510(k) decision of Substantially Equivalent on February 8, 2013, 284 days after the submission was received.
What is the product code of K121280?
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.