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FDA 510(k)

CYTOFLEX MESH

K-Number: K021511 · 2002-08-06

ApplicantUnicare Biomedical, Inc.
Decision Date2002-08-06
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CYTOFLEX MESH 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 2002-08-06 under 510(k) number K021511. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOFLEX MESH?

CYTOFLEX MESH is a medical device that received FDA 510(k) clearance on 2002-08-06. The listed applicant is Unicare Biomedical, Inc.. The 510(k) number is K021511.

When did CYTOFLEX MESH receive FDA 510(k) clearance?

CYTOFLEX MESH received FDA 510(k) clearance on 2002-08-06, under 510(k) number K021511.

Who is the listed applicant for CYTOFLEX MESH?

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 MESH?

The FDA product code for CYTOFLEX MESH is JEY.

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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-005K020720OSSIFORMK012144CYTOFLEX

Related Devices (Code: JEY)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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