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FDA 510(k)

CYTORI PUREGRAFT 250/PURE SYSTEM

K-Number: K092923 · 2010-01-06

ApplicantCytori Therapeutics, Inc.
Decision Date2010-01-06
Product CodeMUU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYTORI PUREGRAFT 250/PURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cytori Therapeutics, Inc.. It received FDA 510(k) clearance on 2010-01-06 under 510(k) number K092923. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTORI PUREGRAFT 250/PURE SYSTEM?

CYTORI PUREGRAFT 250/PURE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-01-06. The listed applicant is Cytori Therapeutics, Inc.. The 510(k) number is K092923.

When did CYTORI PUREGRAFT 250/PURE SYSTEM receive FDA 510(k) clearance?

CYTORI PUREGRAFT 250/PURE SYSTEM received FDA 510(k) clearance on 2010-01-06, under 510(k) number K092923.

Who is the listed applicant for CYTORI PUREGRAFT 250/PURE SYSTEM?

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

What is the FDA product code for CYTORI PUREGRAFT 250/PURE SYSTEM?

The FDA product code for CYTORI PUREGRAFT 250/PURE SYSTEM is MUU.

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Other records listing Cytori Therapeutics, 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.

K113255PUREGRAFT 850/PURE SYSTEMK072587CYTORI AFT SYSTEMK063235CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENTK060482CYTORI CELUTION CELL CONCENTRATION DEVICE

Related Devices (Code: MUU)

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.

K210528IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) KitMillennium Medical Technologies Inc (Dba Cellmyx)K203800SyntrFuge SystemSyntr Health Technologies, Inc.K202443Smart Kit Basic, Smart Kit ProBsl Co., Ltd.K193539REVOLVE ENVI 600 Advanced Adipose SystemLifecell CorporationK193363Dermapose RefreshPuregraft, LLCK182732JTL-250-01Jointechlabs, Inc.

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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