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FDA 510(k)

INJEX 30 NEEDLE FREE INJECTION SYSTEM

K-Number: K022148 · 2002-07-23

ApplicantEquidyne Systems, Inc.
Decision Date2002-07-23
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INJEX 30 NEEDLE FREE INJECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Equidyne Systems, Inc.. It received FDA 510(k) clearance on 2002-07-23 under 510(k) number K022148. 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 INJEX 30 NEEDLE FREE INJECTION SYSTEM?

INJEX 30 NEEDLE FREE INJECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2002-07-23. The listed applicant is Equidyne Systems, Inc.. The 510(k) number is K022148.

When did INJEX 30 NEEDLE FREE INJECTION SYSTEM receive FDA 510(k) clearance?

INJEX 30 NEEDLE FREE INJECTION SYSTEM received FDA 510(k) clearance on 2002-07-23, under 510(k) number K022148.

Who is the listed applicant for INJEX 30 NEEDLE FREE INJECTION SYSTEM?

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

What is the FDA product code for INJEX 30 NEEDLE FREE INJECTION SYSTEM?

The FDA product code for INJEX 30 NEEDLE FREE INJECTION 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 Equidyne Systems, 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.

K022502INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000K003741JET SYRINGE MODEL-100500K003864INJEX 50 SYSTEMK945873HYPEX(TM) JET INJECTOR

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.

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