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FDA 510(k)

ISOSEEDS I-125

K-Number: K021343 · 2002-05-20

ApplicantBebig Isotopen-Und Medizintechnik GmbH
Decision Date2002-05-20
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ISOSEEDS I-125 is the device name listed in this FDA 510(k) record. The listed applicant is Bebig Isotopen-Und Medizintechnik GmbH. It received FDA 510(k) clearance on 2002-05-20 under 510(k) number K021343. 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 ISOSEEDS I-125?

ISOSEEDS I-125 is a medical device that received FDA 510(k) clearance on 2002-05-20. The listed applicant is Bebig Isotopen-Und Medizintechnik GmbH. The 510(k) number is K021343.

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

ISOSEEDS I-125 received FDA 510(k) clearance on 2002-05-20, under 510(k) number K021343.

Who is the listed applicant for ISOSEEDS I-125?

The FDA 510(k) record lists Bebig Isotopen-Und Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOSEEDS I-125?

The FDA product code for ISOSEEDS I-125 is KXK.

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Other records listing Bebig Isotopen-Und Medizintechnik GmbH 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.

K040339BRACHYTHERAPY STRAND DEVICEK033781BEBIG ISOSEED I-125

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

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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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