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FDA 510(k)

Cytrans Granules

K-Number: K192597 · 2020-08-17

ApplicantGC America, Inc.
Decision Date2020-08-17
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Cytrans Granules is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2020-08-17 under 510(k) number K192597. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cytrans Granules?

Cytrans Granules is a medical device that received FDA 510(k) clearance on 2020-08-17. The listed applicant is GC America, Inc.. The 510(k) number is K192597.

When did Cytrans Granules receive FDA 510(k) clearance?

Cytrans Granules received FDA 510(k) clearance on 2020-08-17, under 510(k) number K192597.

Who is the listed applicant for Cytrans Granules?

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

What is the FDA product code for Cytrans Granules?

The FDA product code for Cytrans Granules is LYC.

Other records listing GC America, Inc. as applicant

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Related Devices (Code: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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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