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FDA 510(k)

SuRgical Planner (SRP) BrainStorm

K-Number: K201465 · 2020-07-17

ApplicantSurgical Theater, Inc.
Decision Date2020-07-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SuRgical Planner (SRP) BrainStorm is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Theater, Inc.. It received FDA 510(k) clearance on 2020-07-17 under 510(k) 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. The listed applicant is Surgical Theater, Inc.. The 510(k) number is K201465.

When did SuRgical Planner (SRP) BrainStorm receive FDA 510(k) clearance?

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

Who is the listed applicant for SuRgical Planner (SRP) BrainStorm?

The FDA 510(k) record lists Surgical Theater, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Surgical Theater, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252054SpineAR SNAP (SyncAR Spine)K243623SpineAR SNAP (SyncAR Spine)K213034SpineAR SNAPK170793SuRgical Planner (SRP)K160584Surgical Navigation Advanced Platform (SNAP)

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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.

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