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FDA 510(k)

LEAD BLOCKS

K-Number: K010172 · 2001-04-18

ApplicantArplay Medical S.A.
Decision Date2001-04-18
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LEAD BLOCKS is the device name listed in this FDA 510(k) record. The listed applicant is Arplay Medical S.A.. It received FDA 510(k) clearance on 2001-04-18 under 510(k) number K010172. The device is classified under product code IXI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEAD BLOCKS?

LEAD BLOCKS is a medical device that received FDA 510(k) clearance on 2001-04-18. The listed applicant is Arplay Medical S.A.. The 510(k) number is K010172.

When did LEAD BLOCKS receive FDA 510(k) clearance?

LEAD BLOCKS received FDA 510(k) clearance on 2001-04-18, under 510(k) number K010172.

Who is the listed applicant for LEAD BLOCKS?

The FDA 510(k) record lists Arplay Medical S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEAD BLOCKS?

The FDA product code for LEAD BLOCKS is IXI.

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Other records listing Arplay Medical S.A. 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: IXI)

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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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