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FDA 510(k)

I-125 IMPLANT GUN

K-Number: K850571 · 1985-03-26

ApplicantMick Radio-Nuclear Instruments, Inc.
Decision Date1985-03-26
Product CodeIWJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

I-125 IMPLANT GUN is the device name listed in this FDA 510(k) record. The listed applicant is Mick Radio-Nuclear Instruments, Inc.. It received FDA 510(k) clearance on 1985-03-26 under 510(k) number K850571. The device is classified under product code IWJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-125 IMPLANT GUN?

I-125 IMPLANT GUN is a medical device that received FDA 510(k) clearance on 1985-03-26. The listed applicant is Mick Radio-Nuclear Instruments, Inc.. The 510(k) number is K850571.

When did I-125 IMPLANT GUN receive FDA 510(k) clearance?

I-125 IMPLANT GUN received FDA 510(k) clearance on 1985-03-26, under 510(k) number K850571.

Who is the listed applicant for I-125 IMPLANT GUN?

The FDA 510(k) record lists Mick Radio-Nuclear Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-125 IMPLANT GUN?

The FDA product code for I-125 IMPLANT GUN is IWJ.

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Related Devices (Code: IWJ)

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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