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FDA 510(k)

STARCERAM

K-Number: K133213 · 2013-12-05

ApplicantH.C. Starck Ceramics GmbH
Decision Date2013-12-05
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STARCERAM is the device name listed in this FDA 510(k) record. The listed applicant is H.C. Starck Ceramics GmbH. It received FDA 510(k) clearance on 2013-12-05 under 510(k) number K133213. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STARCERAM?

STARCERAM is a medical device that received FDA 510(k) clearance on 2013-12-05. The listed applicant is H.C. Starck Ceramics GmbH. The 510(k) number is K133213.

When did STARCERAM receive FDA 510(k) clearance?

STARCERAM received FDA 510(k) clearance on 2013-12-05, under 510(k) number K133213.

Who is the listed applicant for STARCERAM?

The FDA 510(k) record lists H.C. Starck Ceramics GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STARCERAM?

The FDA product code for STARCERAM is EIH.

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Related Devices (Code: EIH)

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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