CIV-Clear cover
FDA 510(k) K211270 · CIVCO Medical Instruments Co., Inc.
510(k) numberK211270
Submission
- Device name
- CIV-Clear cover
- Applicant
- CIVCO Medical Instruments Co., Inc.
Kalona, IA, US - Received
- April 27, 2021
- Decision date
- September 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was CIV-Clear cover cleared by the FDA?
CIV-Clear cover (K211270) received a 510(k) decision of Substantially Equivalent on September 13, 2021, 139 days after the submission was received.
What is the product code of K211270?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.