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510(k) K904939

FLEXIBLE AND RIGID URETEROTOME SYSTEM by Olympus Corp. — Product Code EZO

K904939 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "FLEXIBLE AND RIGID URETEROTOME SYSTEM". The FDA issued a decision of Substantially Equivalent on January 7, 1992. The device falls under product code EZO (Urethrotome), a Class II device regulated under 21 CFR 876.4770. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1992
Date Received
November 1, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urethrotome
Device Class
Class II
Regulation Number
876.4770
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)
  • 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)

Other clearances for product code EZO

  • K000905 — URETHROTOME 8667.XXX AND 8670.XXX (May 12, 2000)
  • K950719 — OES UROLOGY (December 11, 1996)
  • K945686 — KARL STORZ KNIVES, CURETTES (February 13, 1995)
  • K934730 — KARL STORZ ENDOSCOPIC COLD KNIFE BLADES (January 11, 1994)

FDA data resources