510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150504Substantially Equivalent

GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor

Pci Medical, Inc., Deep River CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150504 is the FDA 510(k) clearance record for GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor, a class II device, cleared for Pci Medical, Inc. on under FDA product code PSW (High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid). FDA's definition for product code PSW reads: "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...". FDA records list one 510(k) clearance for Pci Medical, Inc. As of , FDA records show no recalls naming K150504.

Clearance record

Decision date
Received
(263 days to decision)
Product code
PSW High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Pci Medical, Inc. 6 Winter Ave., Deep River CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PSW

Trailing 12 months

FDA records hold no clearances under product code PSW in the trailing twelve months.

FDA records show no clearances under product code PSW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PSW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260