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510(k) K053322

MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS by Roei Medical Technologies, Ltd. — Product Code FAS

K053322 is an FDA 510(k) premarket notification submitted by Roei Medical Technologies, Ltd. for the device "MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS". The FDA issued a decision of Substantially Equivalent on January 6, 2006. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Roei Medical Technologies, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2006
Date Received
November 30, 2005
Clearance Type
Special
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 Roei Medical Technologies, Ltd.

  • K050910 — ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS (June 16, 2005)

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