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

FDA 510(k)

Superflow Prime Treatment System (ASP-1M)

K-Number: K242286 · 2024-11-08

ApplicantGuangzhou Aimira Innovation Technology Co, Ltd.
Decision Date2024-11-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Superflow Prime Treatment System (ASP-1M) is a medical device manufactured by Guangzhou Aimira Innovation Technology Co, Ltd.. It received FDA 510(k) clearance on 2024-11-08 under approval number K242286. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Superflow Prime Treatment System (ASP-1M)?

Superflow Prime Treatment System (ASP-1M) is a medical device that received FDA 510(k) clearance on 2024-11-08. It is manufactured by Guangzhou Aimira Innovation Technology Co, Ltd.. The 510(k) number is K242286.

When was Superflow Prime Treatment System (ASP-1M) approved by the FDA?

Superflow Prime Treatment System (ASP-1M) received FDA 510(k) clearance on 2024-11-08, under approval number K242286.

What company makes Superflow Prime Treatment System (ASP-1M)?

Superflow Prime Treatment System (ASP-1M) is manufactured by Guangzhou Aimira Innovation Technology Co, Ltd..

What is the FDA product code for Superflow Prime Treatment System (ASP-1M)?

The FDA product code for Superflow Prime Treatment System (ASP-1M) is GEI.

Related Clinical Trials

NCT07614997 Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck NOT_YET_RECRUITING NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING

Related PubMed Literature

PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025) PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑