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510(k) K964802

CYBERJET LOCAL ANESTHESIA SYSTEM by Intra Vantage, Inc. — Product Code EGM

K964802 is an FDA 510(k) premarket notification submitted by Intra Vantage, Inc. for the device "CYBERJET LOCAL ANESTHESIA SYSTEM". The FDA issued a decision of Substantially Equivalent on May 27, 1997. The device falls under product code EGM (Injector, Jet, Mechanical-Powered), a Class II device regulated under 21 CFR 872.4475.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1997
Date Received
November 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Jet, Mechanical-Powered
Device Class
Class II
Regulation Number
872.4475
Review Panel
DE
Submission Type

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  • K083811 — W&H HANDPIECE ANESTO, MODEL: RA-5 (January 14, 2010)
  • K962017 — HYPODERMIC JET INJECTION APPARATUS (July 26, 1996)
  • K904279 — PAROJECT ANESTHETIC SYRINGE (December 7, 1990)
  • K864294 — HENKE-JECT PRESSURE SYRINGE (MODIFICATION) (November 4, 1987)
  • K864732 — GRADTECH SYRINGE SYSTEM (April 15, 1987)
  • K864861 — INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM (February 13, 1987)
  • K834361 — JSB JET SYRINGE (March 5, 1984)
  • K821273 — MAYO SCISSOR STRAIGHT 6 3/4 (May 28, 1982)
  • K790193 — MIZZY SYRIJET MARK IV (April 23, 1979)

FDA data resources