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FDA 510(k)

`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH

K-Number: K984446 · 1999-04-16

ApplicantUrocor, Inc.
Decision Date1999-04-16
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH is the device name listed in this FDA 510(k) record. The listed applicant is Urocor, Inc.. It received FDA 510(k) clearance on 1999-04-16 under 510(k) number K984446. 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 `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH?

`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH is a medical device that received FDA 510(k) clearance on 1999-04-16. The listed applicant is Urocor, Inc.. The 510(k) number is K984446.

When did `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH receive FDA 510(k) clearance?

`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH received FDA 510(k) clearance on 1999-04-16, under 510(k) number K984446.

Who is the listed applicant for `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH?

The FDA 510(k) record lists Urocor, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH?

The FDA product code for `BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH is KXK.

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Related Devices (Code: KXK)

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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.

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