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510(k) K150504

GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor by Pci Medical, Inc. — Product Code PSW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2015
Date Received
February 26, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
Device Class
Class II
Regulation Number
892.1570
Review Panel
HO
Submission Type

To provide high level disinfection of ultrasound transducers If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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