Aura SP101

• FDA 510(k) K172209 decided 18 May 2018 Active
• FDA GUDID UDI-DI 00860011785200 listed 25 Mar 2024 Listed

1. 18 May 2018 Cleared FDA 510(k) K172209
2. 25 Mar 2024 Listed FDA GUDID 00860011785200

Trade name

Aura

Generic name

Intracerebral sensor catheter, short-term

Model / Ref / Catalog

SP101

Primary DI / UDI-DI

00860011785200

510(k) Number

K172209 ↗

FDA product code

GWM

GMDN term

Intracerebral sensor catheter, short-term

Device class

Class II

Regulation number

882.1620

GUDID distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Category: Intracerebral sensor catheter, short-term

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• CAMINO VENTRICULAR TRANSDUCER ACCESSORY by Camino Laboratories, Inc.
• NEUROSYSTEMS 1TM MONITOR by Neurosystems, LLC
• Stand Holder DATALOGGER 283957-002 by RAUMEDIC AG
• QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT by HEMEDEX INCORPORATED
• B4C System - Addition of new sensor model (BcSs-PICNIW-2000) by Braincare Desenvolvimento E Inovacao Tecnologica S.A.

• Aura SP103

  Class II

  FDA 510(k) K172209 Active Cleared 18 May 2018 GUDID on market

• Aura TB101

  Class II

  FDA 510(k) K172209 Active Cleared 18 May 2018 GUDID on market

• Aura SP102

  Class II

  FDA 510(k) K172209 Active Cleared 18 May 2018 GUDID on market

• Aura TK101

  Class II

  FDA 510(k) K172209 Active Cleared 18 May 2018 GUDID on market

See all devices from Branchpoint & Aura Development LLC →