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510(k) K111517

PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI by Pharmajet, Inc. — Product Code KZE

K111517 is an FDA 510(k) premarket notification submitted by Pharmajet, Inc. for the device "PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI". The FDA issued a decision of Substantially Equivalent on July 27, 2011. The device falls under product code KZE (Injector, Fluid, Non-Electrically Powered), a Class II device regulated under 21 CFR 880.5430. Pharmajet, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2011
Date Received
June 2, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Fluid, Non-Electrically Powered
Device Class
Class II
Regulation Number
880.5430
Review Panel
HO
Submission Type

Other clearances by Pharmajet, Inc.

  • K110456 — PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM (March 2, 2011)
  • K081532 — PHARMAJET NEEDLE-FREE INJECTION SYSTEM (February 26, 2009)

Other clearances for product code KZE

  • K121270 — BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM (July 19, 2012)
  • K110456 — PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM (March 2, 2011)
  • K090959 — LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA (December 24, 2009)
  • K090003 — ZETAJET (April 2, 2009)
  • K081532 — PHARMAJET NEEDLE-FREE INJECTION SYSTEM (February 26, 2009)
  • K082138 — AIRGENT, MODEL AG7000010 (January 23, 2009)
  • K060819 — COOL.CLICK 2 (June 16, 2006)
  • K051985 — BIOVALVE MINI-JECT NEEDLEFREE INJECTOR (August 17, 2005)
  • K050734 — COOL.CLICK (June 3, 2005)
  • K041239 — GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 (November 8, 2004)

FDA data resources