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

FDA 510(k) clearance K150504 · decided 2015-11-16

Clearance details

K-number: K150504
Device name: GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor
Applicant: Pci Medical, Inc.
Decision: Substantially Equivalent
Date received: 2015-02-26
Decision date: 2015-11-16
Days to decision: 263 days
Clearance type: Traditional
Product code: PSW
Device class: 2
Regulation number: 892.1570
Medical specialty: Radiology
Advisory committee: Radiology
Location: Deep River, CT, US
Third-party review: No
Expedited review: No

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator (K233049)	Cs Medical, LLC	2023-11-21
Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator (K230381)	Cs Medical, LLC	2023-06-07
CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant (K192228)	Cs Medical, LLC	2020-04-01
TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants (K182891)	Cs Medical, LLC	2019-04-12
CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant (K160921)	Cs Medical, LLC	2016-11-03
CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD-5 HIGH-LEVEL DISINFECTANT, MODEL TD-5 (K051305)	Cs Medical, LLC	2005-08-18

No recalls on record reference this clearance.