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)

Progenikine Concentrating System 25 mL System

K-Number: K191564 · 2019-11-07

ApplicantEmcyte Corporation
Decision Date2019-11-07
Product CodeMUU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Progenikine Concentrating System 25 mL System is the device name listed in this FDA 510(k) record. The listed applicant is Emcyte Corporation. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K191564. 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 Progenikine Concentrating System 25 mL System?

Progenikine Concentrating System 25 mL System is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Emcyte Corporation. The 510(k) number is K191564.

When did Progenikine Concentrating System 25 mL System receive FDA 510(k) clearance?

Progenikine Concentrating System 25 mL System received FDA 510(k) clearance on 2019-11-07, under 510(k) number K191564.

Who is the listed applicant for Progenikine Concentrating System 25 mL System?

The FDA 510(k) record lists Emcyte Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Progenikine Concentrating System 25 mL System?

The FDA product code for Progenikine Concentrating System 25 mL System is MUU.

Other records listing Emcyte Corporation 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.

K183205PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System

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

View on FDA Database →

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

↑