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)

KOREAN GREEN CROSS SCALP VEIN SET

K-Number: K862289 · 1986-09-23

ApplicantSturbridge Medical
Decision Date1986-09-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KOREAN GREEN CROSS SCALP VEIN SET is the device name listed in this FDA 510(k) record. The listed applicant is Sturbridge Medical. It received FDA 510(k) clearance on 1986-09-23 under 510(k) number K862289. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOREAN GREEN CROSS SCALP VEIN SET?

KOREAN GREEN CROSS SCALP VEIN SET is a medical device that received FDA 510(k) clearance on 1986-09-23. The listed applicant is Sturbridge Medical. The 510(k) number is K862289.

When did KOREAN GREEN CROSS SCALP VEIN SET receive FDA 510(k) clearance?

KOREAN GREEN CROSS SCALP VEIN SET received FDA 510(k) clearance on 1986-09-23, under 510(k) number K862289.

Who is the listed applicant for KOREAN GREEN CROSS SCALP VEIN SET?

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

What is the FDA product code for KOREAN GREEN CROSS SCALP VEIN SET?

The FDA product code for KOREAN GREEN CROSS SCALP VEIN SET is FPA.

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 Sturbridge Medical 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.

K860242JMS INFUSION SET

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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.

↑