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FDA 510(k)

CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41

K-Number: K852023 · 1985-08-21

ApplicantSyncor Intl. Corp.
Decision Date1985-08-21
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 is the device name listed in this FDA 510(k) record. The listed applicant is Syncor Intl. Corp.. It received FDA 510(k) clearance on 1985-08-21 under 510(k) number K852023. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41?

CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 is a medical device that received FDA 510(k) clearance on 1985-08-21. The listed applicant is Syncor Intl. Corp.. The 510(k) number is K852023.

When did CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 receive FDA 510(k) clearance?

CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 received FDA 510(k) clearance on 1985-08-21, under 510(k) number K852023.

Who is the listed applicant for CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41?

The FDA 510(k) record lists Syncor Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41?

The FDA product code for CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 is KXK.

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Other records listing Syncor Intl. Corp. 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.

K945825SECURE SAFETY INSERTK851828IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-CK850433CESIUM 137 ENDOMETRIAL SOURCEK852665SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAYK851033SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KITK844735PTH-RIA

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Related Devices (Code: KXK)

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.

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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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