FDA 510(k)

PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI

K-Number: K111517 · 2011-07-27

Decision Date2011-07-27

Product CodeKZE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI is the device name listed in this FDA 510(k) record. The listed applicant is Pharmajet, Inc.. It received FDA 510(k) clearance on 2011-07-27 under 510(k) number K111517. 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 PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI?

PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI is a medical device that received FDA 510(k) clearance on 2011-07-27. The listed applicant is Pharmajet, Inc.. The 510(k) number is K111517.

When did PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI receive FDA 510(k) clearance?

PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI received FDA 510(k) clearance on 2011-07-27, under 510(k) number K111517.

Who is the listed applicant for PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI?

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

What is the FDA product code for PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI?

The FDA product code for PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pharmajet, Inc. as applicant

K110456PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM K081532PHARMAJET NEEDLE-FREE INJECTION SYSTEM

Related Devices (Code: KZE)

K121270BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEMBioject Medical Technologies, 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.K082138AIRGENT, MODEL AG7000010Perfaction, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.