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510(k) K904668

IE MAGNETIC EXTRACTOR by Olympus Corp. — Product Code FCC

K904668 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "IE MAGNETIC EXTRACTOR". The FDA issued a decision of Substantially Equivalent on March 21, 1991. The device falls under product code FCC (Endoscopic Magnetic Retriever), 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
March 21, 1991
Date Received
October 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Magnetic Retriever
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

to endoscopically retrieve magnetic foreign objects

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 FCC

  • K843135 — BRIMFIELD CANNULATED MAGNETIC RETRIEVER (September 26, 1984)
  • K800971 — M.R. ASSOC. MAGNETIC EXTRACTOR (May 8, 1980)

FDA data resources