Burr Hole Cover, Model XX
FDA 510(k) K001096 · Image-Guided Neurologics, Inc.
510(k) numberK001096
Submission
- Device name
- Burr Hole Cover, Model XX
- Applicant
- Image-Guided Neurologics, Inc.
Melbourne, FL, US - Received
- April 4, 2000
- Decision date
- October 25, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K160739 | Cranial COVERGXR · Traditional | Neos Surgery S.L | 06/12/2016SE |
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Questions and answers
When was Burr Hole Cover, Model XX cleared by the FDA?
Burr Hole Cover, Model XX (K001096) received a 510(k) decision of Substantially Equivalent on October 25, 2000, 204 days after the submission was received.
What is the product code of K001096?
The FDA product code is GXR – Cover, Burr Hole, a Class II (moderate risk) device regulated under 21 CFR 882.5250.