Atlas FDA

Becker External Drainage and Monitoring System

FDA 510(k) clearance K200456 · decided 2020-03-26

Clearance details

K-number
K200456
Device name
Becker External Drainage and Monitoring System
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2020-02-25
Decision date
2020-03-26
Days to decision
30 days
Clearance type
Special
Product code
GWM
Device class
2
Regulation number
882.1620
Medical specialty
Neurology
Advisory committee
Neurology
Location
Goleta, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 ED recall (Z-0661-2025)Medtronic Neurosurgery2024-12-19
Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27 recall (Z-0662-2025)Medtronic Neurosurgery2024-12-19

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