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510(k) K790071

ENDOSCOPE AND ACCESSORIES by Olympus Corp. — Product Code GCP

K790071 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "ENDOSCOPE AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on April 2, 1979. The device falls under product code GCP (Endoscope, Ac-Powered And Accessories), 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 2, 1979
Date Received
January 11, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Ac-Powered And Accessories
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 GCP

  • K954614 — EOS BRAND DISPOSABLE PROCTOSCOPE (April 10, 1996)
  • K896505 — PORGES UNIVERSAL HANDLES (January 30, 1990)
  • K896008 — MODEL 6500 MERCURY ARC LIGHT SOURCE (December 27, 1989)
  • K862424 — STEERABLE CATHETER SYSTEM (September 22, 1986)
  • K860103 — MOD. ENDOPORT SINGLE-USE TROCAR AND SLEEVE (February 12, 1986)
  • K843683 — MODULAR FIBERSCOPE SYSTEM (January 18, 1985)
  • K833859 — TAMPONADE BALLOON CUFF (January 3, 1984)
  • K821999 — ENDOSCOPIC SCLEROTHERAPY BALLOON (August 27, 1982)
  • K801247 — CCD ENDOSCOPE AND ATTACHMENTS (July 28, 1980)
  • K771920 — FIBER OPTICS PROCTOSCOPE (October 20, 1977)

FDA data resources