Biopsy Needle Transponder System
FDA 510(k) K902214 · Advanced Technology Laboratories, Inc.
510(k) numberK902214
Submission
- Device name
- Biopsy Needle Transponder System
- Applicant
- Advanced Technology Laboratories, Inc.
Bothell, WA, US - Received
- May 16, 1990
- Decision date
- November 8, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Biopsy Needle Transponder System cleared by the FDA?
Biopsy Needle Transponder System (K902214) received a 510(k) decision of Substantially Equivalent on November 8, 1990, 176 days after the submission was received.
What is the product code of K902214?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.