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510(k) K903529

BML SERIES by Olympus Corp. — Product Code LQC

K903529 is an FDA 510(k) premarket notification submitted by Olympus Corp. for the device "BML SERIES". The FDA issued a decision of Substantially Equivalent on January 23, 1991. The device falls under product code LQC (Lithotriptor, Biliary Mechanical), a Class II device regulated under 21 CFR 876.4500. Olympus Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1991
Date Received
August 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Biliary Mechanical
Device Class
Class II
Regulation Number
876.4500
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 LQC

  • K040447 — TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 (March 12, 2004)
  • K011178 — WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR (May 4, 2001)
  • K964937 — A LITHOTRIPTER-COMPATIBLE BASKET (January 24, 1997)
  • K942544 — GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS (November 22, 1994)
  • K943191 — MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR (August 29, 1994)
  • K905552 — LAPAROLITH (December 17, 1991)
  • K911364 — SPOON FORCEPS, 11MM (October 23, 1991)
  • K911477 — LAPAROSCOPIC BASKET FLEXIBLE AND RIGID (August 14, 1991)
  • K902170 — SOEHENDRA LITHOTRIPSY SET (July 25, 1990)
  • K860863 — ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER (May 15, 1986)

FDA data resources