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510(k) K850978

OLYMPUS LF-1 INTUBATION SCOPE by Olympus Corp. — Product Code CAL

K850978 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "OLYMPUS LF-1 INTUBATION SCOPE". The FDA issued a decision of Substantially Equivalent on May 23, 1985. The device falls under product code CAL (Laryngoscope, Non-Rigid), a Class I device regulated under 21 CFR 868.5530. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1985
Date Received
March 8, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Non-Rigid
Device Class
Class I
Regulation Number
868.5530
Review Panel
AN
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 CAL

  • K951195 — FI-10P (April 6, 1995)
  • K951194 — FI-10M (April 6, 1995)
  • K872895 — HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. (January 11, 1988)
  • K852994 — REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11 (July 29, 1985)
  • K802331 — AO FLEXIBLE LARYNGOSCOPE, #LS-7 (October 10, 1980)
  • K801364 — AO STYLET LARYNGOSCOPE MODEL SLS (June 17, 1980)
  • K791634 — AO STYLET LARYNGOSCOPE, MODEL SLS-1 (September 17, 1979)

FDA data resources