SYMBIS Surgical System
FDA 510(k) K143420 · Imris, Inc.
510(k) numberK143420
Submission
- Device name
- SYMBIS Surgical System
- Applicant
- Imris, Inc.
Minnetonka, MN, US - Received
- November 28, 2014
- Decision date
- October 30, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was SYMBIS Surgical System cleared by the FDA?
SYMBIS Surgical System (K143420) received a 510(k) decision of Substantially Equivalent on October 30, 2015, 336 days after the submission was received.
What is the product code of K143420?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.