Home / 510(k) Clearances / K981463

510(k) K981463

OMNITECH RESECTOSCOPE ROLLER ELECTRODE by Omnitech Systems, Inc. — Product Code KNF

K981463 is an FDA 510(k) premarket notification submitted by Omnitech Systems, Inc. for the device "OMNITECH RESECTOSCOPE ROLLER ELECTRODE". The FDA issued a decision of Substantially Equivalent on July 17, 1998. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Omnitech Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1998
Date Received
April 23, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4160
Review Panel
OB
Submission Type

Other clearances by Omnitech Systems, Inc.

  • K151976 — Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (June 27, 2016)
  • K050454 — OMNITECH FULGURATING ELECTRODE (May 27, 2005)
  • 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 KNF

  • K250705 — Sonata Transcervical Fibroid Ablation System 2.2 (April 2, 2025)
  • K240503 — Sonata Transcervical Fibroid Ablation System 2.2 (July 17, 2024)
  • K233848 — Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) (December 21, 2023)
  • K222304 — Sonata Transcervical Fibroid Ablation System 2.2 (November 8, 2022)
  • K211535 — Sonata Transcervical Fibroid Ablation System 2.2 (June 17, 2021)
  • K193516 — Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 (May 4, 2020)
  • K173703 — Sonata Sonography-Guided Transcervical Fibroid Ablation System (August 15, 2018)
  • K132135 — LINA GOLD LOOP HC (January 31, 2014)
  • K121343 — MODULAP LOOP (June 14, 2013)
  • K103726 — JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS (February 8, 2012)

FDA data resources