Modification to: Microblade Shaver and Accessories
FDA 510(k) K100958 · Baxano, Inc.
510(k) numberK100958
Submission
- Device name
- Modification to: Microblade Shaver and Accessories
- Applicant
- Baxano, Inc.
San Jose, CA, US - Received
- April 7, 2010
- Decision date
- July 23, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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More from Symmetry Surgical, Inc.
| 510(k) | Device | Decision |
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| K113073 | Io-Tome DeviceHAE · Traditional | 07/27/2012SE |
| K113533 | Neuro Check Device with Io-Flex WireHAE · Special | 04/11/2012SE |
| K110696 | Neuro Check Device with Io-Flex WireETN · Traditional | 07/07/2011SE |
| K102594 | Io-Flex CatheterBSO · Traditional | 01/19/2011SE |
| K092729 | Baxano Neuro Check DeviceETN · Special | 10/02/2009SE |
| K081742 | Baxano Neural Localization Probe 1.75 and 1.25ETN · Traditional | 09/17/2008SE |
| K080494 | Baxano Ultra Low Profile RongeurHAE · Special | 03/04/2008SE |
| K063231 | Microblade Shaver and AccessoriesHAE · Traditional | 04/16/2007SE |
| K062711 | Ultra Low Profile RongeurHAE · Traditional | 03/07/2007SE |
Questions and answers
When was Modification to: Microblade Shaver and Accessories cleared by the FDA?
Modification to: Microblade Shaver and Accessories (K100958) received a 510(k) decision of Substantially Equivalent on July 23, 2010, 107 days after the submission was received.
What is the product code of K100958?
The FDA product code is HAE – Rongeur, Manual, a Class II (moderate risk) device regulated under 21 CFR 882.4840.