Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model Ua 1336, Needle Guide for 8824, Model Ua 1337
FDA 510(k) K083667 · B-K Medical Aps
510(k) numberK083667
Submission
- Device name
- Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model Ua 1336, Needle Guide for 8824, Model Ua 1337
- Applicant
- B-K Medical Aps
Herlev, DK - Received
- December 11, 2008
- Decision date
- February 2, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K250524 | Mendaera Guidance SystemITX · Traditional | Mendaera, Inc. | 07/02/2025SE |
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| K132677 | Ultrasound Scanner Flex Focus 1202IYN · Traditional | 01/07/2014SE |
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| K123254 | Ultrasound Scanner Flex FocusIYN · Traditional | 02/13/2013SE |
| K100919 | Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202IYN · Traditional | 12/16/2011SE |
| K081323 | Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818FCG · Traditional | 07/22/2008SE |
| K081154 | Ultrasound Scanner Flex Focus, Model 1202IYO · Special | 05/23/2008SE |
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Questions and answers
When was Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model Ua 1336, Needle Guide for 8824, Model Ua 1337 cleared by the FDA?
Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model Ua 1336, Needle Guide for 8824, Model Ua 1337 (K083667) received a 510(k) decision of Substantially Equivalent on February 2, 2009, 53 days after the submission was received.
What is the product code of K083667?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.