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510(k) K882061

OLYMPUS GF-UM3/EU-M3 by Olympus Corp. — Product Code GDB

K882061 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "OLYMPUS GF-UM3/EU-M3". The FDA issued a decision of Substantially Equivalent on November 15, 1988. The device falls under product code GDB (Endoscope, Fiber Optic), 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
November 15, 1988
Date Received
May 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Fiber Optic
Device Class
Class II
Regulation Number
876.1500
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 GDB

  • K032283 — DESIGNS FOR VISION FIBEROPTIC LIGHT (August 20, 2003)
  • K961536 — FLEXSCOPE (September 18, 1996)
  • K935818 — ENDOSCOPE (July 13, 1994)
  • K855151 — FRITCH OPHTHALMIC ENDOSCOPE (February 19, 1986)
  • K843900 — FOCUSCOPE UNIVERSAL SYSTEM (December 6, 1984)
  • K810007 — PENTAX UPPER G.I. FIBERSCOPE, #FG-34 (January 15, 1981)

FDA data resources