FDA 510(k)

SuRgical Planner (SRP) BrainStorm

K-Number: K201465 · 2020-07-17

Decision Date2020-07-17

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SuRgical Planner (SRP) BrainStorm is a medical device manufactured by Surgical Theater, Inc.. It received FDA 510(k) clearance on 2020-07-17 under approval number K201465. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SuRgical Planner (SRP) BrainStorm?

SuRgical Planner (SRP) BrainStorm is a medical device that received FDA 510(k) clearance on 2020-07-17. It is manufactured by Surgical Theater, Inc.. The 510(k) number is K201465.

When was SuRgical Planner (SRP) BrainStorm approved by the FDA?

SuRgical Planner (SRP) BrainStorm received FDA 510(k) clearance on 2020-07-17, under approval number K201465.

What company makes SuRgical Planner (SRP) BrainStorm?

SuRgical Planner (SRP) BrainStorm is manufactured by Surgical Theater, Inc..

What is the FDA product code for SuRgical Planner (SRP) BrainStorm?

The FDA product code for SuRgical Planner (SRP) BrainStorm is LLZ.

Other Devices by Surgical Theater, Inc.

K213034SpineAR SNAP K243623SpineAR SNAP (SyncAR Spine) K252054SpineAR SNAP (SyncAR Spine)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.