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FDA 510(k)

GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES

K-Number: K050666 · 2005-04-11

ApplicantBerkeley Advanced Biomaterials, Inc.
Decision Date2005-04-11
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Berkeley Advanced Biomaterials, Inc.. It received FDA 510(k) clearance on 2005-04-11 under 510(k) number K050666. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES?

GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES is a medical device that received FDA 510(k) clearance on 2005-04-11. The listed applicant is Berkeley Advanced Biomaterials, Inc.. The 510(k) number is K050666.

When did GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES receive FDA 510(k) clearance?

GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES received FDA 510(k) clearance on 2005-04-11, under 510(k) number K050666.

Who is the listed applicant for GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES?

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

What is the FDA product code for GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES?

The FDA product code for GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES is MQV.

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Other records listing Berkeley Advanced Biomaterials, Inc. 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.

K113791B-GENIN, R-GENINK091912B-GENIN AND R-GENINK092046BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTYK053213BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAMK051914GENEROS 80, GENEROS 60K051695MARROW PLUS (M+)

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Related Devices (Code: MQV)

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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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