Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT

K-Number: K063235 · 2007-01-24

ApplicantCytori Therapeutics, Inc.
Decision Date2007-01-24
Product CodeQPB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT 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 2007-01-24 under 510(k) number K063235. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT?

CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT is a medical device that received FDA 510(k) clearance on 2007-01-24. The listed applicant is Cytori Therapeutics, Inc.. The 510(k) number is K063235.

When did CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT receive FDA 510(k) clearance?

CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT received FDA 510(k) clearance on 2007-01-24, under 510(k) number K063235.

Who is the listed applicant for CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT?

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 LIPOPLASTY SYSTEM WITH CELASE REAGENT?

The FDA product code for CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT is QPB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK092923CYTORI PUREGRAFT 250/PURE SYSTEMK072587CYTORI AFT SYSTEMK060482CYTORI CELUTION CELL CONCENTRATION DEVICE

Related Devices (Code: QPB)

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.

K254135LipoSurg ARTISTNOUVAG AGK261710AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula AdaptorsApyx Medical CorporationK251944Lipocosm Harmonic SystemLipocosm, LLCK253396AYON Body Contouring System™ (AYON SYSTEM)Apyx Medical CorporationK252495LSSA (NP-200)Newpong Co., Ltd.K244050AYON Body Contouring System (AYON SYSTEM)Apyx Medical Corporation

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.

↑