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FDA 510(k)

Celesteion, PCA-9000A/3

K-Number: K170490 · 2017-06-01

Decision Date2017-06-01
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Celesteion, PCA-9000A/3 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K170490. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Celesteion, PCA-9000A/3?

Celesteion, PCA-9000A/3 is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K170490.

When did Celesteion, PCA-9000A/3 receive FDA 510(k) clearance?

Celesteion, PCA-9000A/3 received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170490.

Who is the listed applicant for Celesteion, PCA-9000A/3?

The FDA 510(k) record lists Toshibamedical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Celesteion, PCA-9000A/3?

The FDA product code for Celesteion, PCA-9000A/3 is KPS.

Other records listing Toshibamedical Systems Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 27 devices →

Related Devices (Code: KPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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