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FDA 510(k)

CYTOFLEX

K-Number: K012144 · 2001-10-01

ApplicantUnicare Biomedical, Inc.
Decision Date2001-10-01
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CYTOFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Unicare Biomedical, Inc.. It received FDA 510(k) clearance on 2001-10-01 under 510(k) number K012144. 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 CYTOFLEX?

CYTOFLEX is a medical device that received FDA 510(k) clearance on 2001-10-01. The listed applicant is Unicare Biomedical, Inc.. The 510(k) number is K012144.

When did CYTOFLEX receive FDA 510(k) clearance?

CYTOFLEX received FDA 510(k) clearance on 2001-10-01, under 510(k) number K012144.

Who is the listed applicant for CYTOFLEX?

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

What is the FDA product code for CYTOFLEX?

The FDA product code for CYTOFLEX is LYC.

Related Clinical Trials

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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Other records listing Unicare Biomedical, 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.

K092567MODIFICATION TO UNIGRAFTK090083CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090K080532BENACEL, MODELS C-001, C-002 AND C-005K021511CYTOFLEX MESHK020720OSSIFORM

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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