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)

CORELEADER COLLA-PAD MODEL CS 03030

K-Number: K102946 · 2011-05-20

ApplicantCoreleader Biotech Co., Ltd.
Decision Date2011-05-20
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

CORELEADER COLLA-PAD MODEL CS 03030 is the device name listed in this FDA 510(k) record. The listed applicant is Coreleader Biotech Co., Ltd.. It received FDA 510(k) clearance on 2011-05-20 under 510(k) number K102946. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORELEADER COLLA-PAD MODEL CS 03030?

CORELEADER COLLA-PAD MODEL CS 03030 is a medical device that received FDA 510(k) clearance on 2011-05-20. The listed applicant is Coreleader Biotech Co., Ltd.. The 510(k) number is K102946.

When did CORELEADER COLLA-PAD MODEL CS 03030 receive FDA 510(k) clearance?

CORELEADER COLLA-PAD MODEL CS 03030 received FDA 510(k) clearance on 2011-05-20, under 510(k) number K102946.

Who is the listed applicant for CORELEADER COLLA-PAD MODEL CS 03030?

The FDA 510(k) record lists Coreleader Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORELEADER COLLA-PAD MODEL CS 03030?

The FDA product code for CORELEADER COLLA-PAD MODEL CS 03030 is KGN.

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 Coreleader Biotech Co., Ltd. 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.

K123394CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSINGK111578CORELEADER COLLA-ALGI FIBER MODEL CAWK111733CORELEADER SCAR-DIMMERK102944CORELEADER HEMO-PAD MODEL CPII 02030K102942CORELEADER ALGIPLASTER MODEL AP 050501K102943CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050

View all 7 devices →

Related Devices (Code: KGN)

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.

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced BiomaterialsK260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, 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.

↑