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510(k) K983200

INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX by Ximed/Prosure/Injectx — Product Code GAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1998
Date Received
September 14, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Ximed/Prosure/Injectx

  • K002269 — ELECTROSURGICAL PROBES AND DEVICES-GELTX (January 4, 2001)
  • K994151 — PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES (March 1, 2000)
  • K983765 — INJECTION NEEDLE PROBE/DEVICE-TUNIS (December 11, 1998)
  • K981256 — ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE (May 12, 1998)
  • K974484 — ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE (February 10, 1998)
  • K974637 — ELECTRODES/PROBES/DEVICES (January 7, 1998)
  • K962593 — ELECTROSURGICAL PROBES & DEVICES (November 12, 1996)
  • K945995 — BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS (January 31, 1995)

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  • K011586 — IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE (November 16, 2001)
  • K994151 — PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES (March 1, 2000)
  • K974741 — MANAN ACCURA NEEDLE (January 8, 1998)
  • K962425 — BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) (September 11, 1996)
  • K961959 — MD TECH BIOPSY SET FOR BONE AND BONE MARROW (July 19, 1996)
  • K945109 — MONOJECT BONE MARROW BIOPSY TRAYS (November 14, 1994)
  • K940025 — MANAN BONE MARROW HARVEST NEEDLES (February 25, 1994)
  • K940024 — MANAN GENERAL PURPOSE INTRODUCER NEEDLE (February 25, 1994)