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FDA 510(k)

IRIDIUM 192 WIRES

K-Number: K850163 · 1985-03-26

ApplicantSyncor Intl. Corp.
Decision Date1985-03-26
Product CodeIWA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IRIDIUM 192 WIRES 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 1985-03-26 under 510(k) number K850163. The device is classified under product code IWA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRIDIUM 192 WIRES?

IRIDIUM 192 WIRES is a medical device that received FDA 510(k) clearance on 1985-03-26. The listed applicant is Syncor Intl. Corp.. The 510(k) number is K850163.

When did IRIDIUM 192 WIRES receive FDA 510(k) clearance?

IRIDIUM 192 WIRES received FDA 510(k) clearance on 1985-03-26, under 510(k) number K850163.

Who is the listed applicant for IRIDIUM 192 WIRES?

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 IRIDIUM 192 WIRES?

The FDA product code for IRIDIUM 192 WIRES is IWA.

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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 SOURCEK852023CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41K852665SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAYK851033SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT

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Related Devices (Code: IWA)

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.

K915253IR-192 IMPLANT, MODIFICATIONOmnitron Intl., Inc.K894409CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELDAmersham Corp.K874895IR-192 IMPLANTRads S.L., Inc.K850382IRIDIUM SEEDSRadiation Safety & Nuclear Products, Inc.K844248IR-192 IMPLANTRads S.L., Inc.K850726WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELDSyncor Intl. Corp.

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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