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510(k) K931763

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

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.

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  • 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)

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