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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

K150504 is an FDA 510(k) premarket notification submitted by Pci Medical, Inc. for the device "GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor". The FDA issued a decision of Substantially Equivalent on November 16, 2015. The device falls under product code PSW (High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid), a Class II device regulated under 21 CFR 892.1570.

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).

Other clearances for product code PSW

  • K233049 — TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with (November 21, 2023)
  • K230381 — Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High- (June 7, 2023)
  • K192228 — CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD- (April 1, 2020)
  • K182891 — TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and (April 12, 2019)
  • K160921 — CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Me (November 3, 2016)
  • K051305 — CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD (August 18, 2005)

FDA data resources