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510(k) K050454

OMNITECH FULGURATING ELECTRODE by Omnitech Systems, Inc. — Product Code FAS

K050454 is an FDA 510(k) premarket notification submitted by Omnitech Systems, Inc. for the device "OMNITECH FULGURATING ELECTRODE". The FDA issued a decision of Substantially Equivalent on May 27, 2005. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Omnitech Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2005
Date Received
February 22, 2005
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 Omnitech Systems, Inc.

  • K151976 — Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (June 27, 2016)
  • K981463 — OMNITECH RESECTOSCOPE ROLLER ELECTRODE (July 17, 1998)
  • K981464 — OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE (July 10, 1998)
  • K964365 — RESECTOSCOPE CUTTING LOOP ELECTRODE (April 22, 1997)
  • K965093 — OMNITECH RESECTOSCOPE ROLLER ELECTRODE (March 19, 1997)

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