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U.S. Department of Health and Human Services

Product Classification

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Device needle, interosseous
Regulation Description Hypodermic single lumen needle.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeMHC
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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