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510(k) K931763

HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS by Olympus Corp. — Product Code FAS

K931763 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS". The FDA issued a decision of Substantially Equivalent on August 29, 1994. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1994
Date Received
April 8, 1993
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 Olympus Corp.

  • K915402 — EW-10 AND EW-20 (June 23, 1995)
  • K933200 — OLYMPUS PBD STENTS (April 5, 1995)
  • K942338 — OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES (November 30, 1994)
  • K934835 — FLOVAL (June 21, 1994)
  • K931764 — HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES (June 8, 1994)
  • K915857 — FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE (March 11, 1994)
  • K931994 — RESECTOSCOPE SHEATH (February 17, 1994)
  • K934889 — OLYMPUS IMAGEMANAGER SYSTEM (January 28, 1994)
  • K934888 — OLYMPUS IMAGEMANAGERSYSTEM (January 25, 1994)
  • K933992 — OLYMPUS SCLEROTHERAPY BALLOON (December 21, 1993)

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