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510(k) K974637

ELECTRODES/PROBES/DEVICES by Ximed/Prosure/Injectx — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1998
Date Received
December 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical, Active, Urological
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
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)
  • K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (December 11, 1998)
  • K981256 — ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE (May 12, 1998)
  • K974484 — ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE (February 10, 1998)
  • K962593 — ELECTROSURGICAL PROBES & DEVICES (November 12, 1996)
  • K945995 — BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS (January 31, 1995)

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