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510(k) K810503

FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE by Olympus Corp. — Product Code NWS

K810503 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE". The FDA issued a decision of Substantially Equivalent on April 3, 1981. The device falls under product code NWS (Kit, Choledochoscope, Flexible And Rigid), a Class II device regulated under 21 CFR 876.1500. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1981
Date Received
February 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Choledochoscope, Flexible And Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Flexible and Rigid Choledochoscope Kit

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)
  • K931763 — HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS (August 29, 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)

FDA data resources