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FDA 510(k)

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

K-Number: K163313 · 2017-06-09

ApplicantCIVCO Medical Instruments Co., Inc.
Decision Date2017-06-09
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor is a medical device manufactured by CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 2017-06-09 under approval number K163313. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor?

ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor is a medical device that received FDA 510(k) clearance on 2017-06-09. It is manufactured by CIVCO Medical Instruments Co., Inc.. The 510(k) number is K163313.

When was ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor approved by the FDA?

ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor received FDA 510(k) clearance on 2017-06-09, under approval number K163313.

What company makes ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor?

ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor is manufactured by CIVCO Medical Instruments Co., Inc..

What is the FDA product code for ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor?

The FDA product code for ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor is ITX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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