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SRP BrainStorm

by Surgical Theater LLC

SRP BrainStorm is a surgical simulation system (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Surgical Theater LLC, cleared under FDA 510(k) K201465 on 17 Jul 2020 and listed in FDA GUDID since 8 Dec 2020 (UDI-DI 00860003884119), active as of 21 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K201465

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860003884119 UDI-DI Date8 Dec 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201465 Date17 Jul 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201465 decided 17 Jul 2020 Active
  • FDA GUDID UDI-DI 00860003884119 listed 8 Dec 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-0325-2026 FDA Class II initiated 16 Sep 2025

    A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K201465
  2. Listed FDA GUDID 00860003884119
  3. Recall initiated FDA recalls Z-0325-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Surgical simulation system
Model / reference
BrainStorm
Primary DI / UDI-DI
00860003884119
510(k) Number
FDA product code
LLZ
GMDN term
Surgical simulation system
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical simulation system

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from Surgical Theater LLC

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    Class II

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  • All-in-One Clinic Viewer

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See all devices from Surgical Theater LLC →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)