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FDA 510(k)

THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06

K-Number: K043596 · 2005-01-26

ApplicantTheragenics Corp.
Decision Date2005-01-26
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 is the device name listed in this FDA 510(k) record. The listed applicant is Theragenics Corp.. It received FDA 510(k) clearance on 2005-01-26 under 510(k) number K043596. 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 THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06?

THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 is a medical device that received FDA 510(k) clearance on 2005-01-26. The listed applicant is Theragenics Corp.. The 510(k) number is K043596.

When did THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 receive FDA 510(k) clearance?

THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 received FDA 510(k) clearance on 2005-01-26, under 510(k) number K043596.

Who is the listed applicant for THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06?

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

What is the FDA product code for THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06?

The FDA product code for THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 is KXK.

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Other records listing Theragenics 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.

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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

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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