GALAXY G3 Mini Microcoil Delivery System
FDA 510(k) K171862 · Codman & Shurtleff, Inc.
510(k) numberK171862
Submission
- Device name
- GALAXY G3 Mini Microcoil Delivery System
- Applicant
- Codman & Shurtleff, Inc.
Raynham, MA, US - Received
- June 22, 2017
- Decision date
- September 25, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was GALAXY G3 Mini Microcoil Delivery System cleared by the FDA?
GALAXY G3 Mini Microcoil Delivery System (K171862) received a 510(k) decision of Substantially Equivalent on September 25, 2017, 95 days after the submission was received.
What is the product code of K171862?
The FDA product code is HCG – Device, Neurovascular Embolization, a Class II (moderate risk) device regulated under 21 CFR 882.5950.