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)

BI-3M NEEDLE-FREE INJECTOR SYSTEM

K-Number: K013256 · 2001-12-07

ApplicantFelton International, Inc.
Decision Date2001-12-07
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BI-3M NEEDLE-FREE INJECTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Felton International, Inc.. It received FDA 510(k) clearance on 2001-12-07 under 510(k) number K013256. The device is classified under product code KZE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BI-3M NEEDLE-FREE INJECTOR SYSTEM?

BI-3M NEEDLE-FREE INJECTOR SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-07. The listed applicant is Felton International, Inc.. The 510(k) number is K013256.

When did BI-3M NEEDLE-FREE INJECTOR SYSTEM receive FDA 510(k) clearance?

BI-3M NEEDLE-FREE INJECTOR SYSTEM received FDA 510(k) clearance on 2001-12-07, under 510(k) number K013256.

Who is the listed applicant for BI-3M NEEDLE-FREE INJECTOR SYSTEM?

The FDA 510(k) record lists Felton International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BI-3M NEEDLE-FREE INJECTOR SYSTEM?

The FDA product code for BI-3M NEEDLE-FREE INJECTOR SYSTEM is KZE.

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 Felton International, 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.

K041280HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500

Related Devices (Code: KZE)

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.

K121270BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEMBioject Medical Technologies, Inc.K111517PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATIPharmajet, Inc.K110456PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEMPharmajet, Inc.K090959LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RAD'Antonio Consultants International, Inc. (Dci)K090003ZETAJETBioject, Inc.K081532PHARMAJET NEEDLE-FREE INJECTION SYSTEMPharmajet, 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.

↑