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510(k) K974637

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

K974637 is an FDA 510(k) premarket notification submitted by Ximed/Prosure/Injectx for the device "ELECTRODES/PROBES/DEVICES". The FDA issued a decision of Substantially Equivalent on January 7, 1998. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Ximed/Prosure/Injectx has at least 8 other 510(k) clearances on record.

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)
  • K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (December 11, 1998)
  • 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)
  • K962593 — ELECTROSURGICAL PROBES & DEVICES (November 12, 1996)
  • K945995 — BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS (January 31, 1995)

Other clearances for product code FAS

  • K251403 — Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Elect (December 5, 2025)
  • K250522 — Multi4 System (June 27, 2025)
  • K240504 — PLASMA EDGE System (June 12, 2024)
  • K213135 — Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, (March 2, 2022)
  • K210651 — Resection Electrodes with HF cable (August 3, 2021)
  • K210394 — Electrosurgical accessory (May 19, 2021)
  • K171965 — Resection Electrodes with HF cable (September 28, 2017)
  • K163090 — Plasma Edge System (May 23, 2017)
  • K151976 — Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (June 27, 2016)
  • K152092 — Resection Electrodes (October 26, 2015)

FDA data resources