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FDA 510(k)

IRIDIUM SEEDS

K-Number: K850382 · 1985-08-15

ApplicantRadiation Safety & Nuclear Products, Inc.
Decision Date1985-08-15
Product CodeIWA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IRIDIUM SEEDS is the device name listed in this FDA 510(k) record. The listed applicant is Radiation Safety & Nuclear Products, Inc.. It received FDA 510(k) clearance on 1985-08-15 under 510(k) number K850382. 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 SEEDS?

IRIDIUM SEEDS is a medical device that received FDA 510(k) clearance on 1985-08-15. The listed applicant is Radiation Safety & Nuclear Products, Inc.. The 510(k) number is K850382.

When did IRIDIUM SEEDS receive FDA 510(k) clearance?

IRIDIUM SEEDS received FDA 510(k) clearance on 1985-08-15, under 510(k) number K850382.

Who is the listed applicant for IRIDIUM SEEDS?

The FDA 510(k) record lists Radiation Safety & Nuclear Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRIDIUM SEEDS?

The FDA product code for IRIDIUM SEEDS is IWA.

Related Clinical Trials

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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Other records listing Radiation Safety & Nuclear Products, Inc. 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.

K834027GOLD SEADS

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.K844248IR-192 IMPLANTRads S.L., Inc.K850726WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELDSyncor Intl. Corp.K850163IRIDIUM 192 WIRESSyncor 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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