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510(k) K964937

A LITHOTRIPTER-COMPATIBLE BASKET by Boston Scientific Corp — Product Code LQC

K964937 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "A LITHOTRIPTER-COMPATIBLE BASKET". The FDA issued a decision of Substantially Equivalent on January 24, 1997. The device falls under product code LQC (Lithotriptor, Biliary Mechanical), a Class II device regulated under 21 CFR 876.4500. Boston Scientific Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1997
Date Received
December 10, 1996
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 Boston Scientific Corp

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  • K252910 — Orca Air/Water and Suction Valves (October 9, 2025)
  • K251291 — Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery (July 3, 2025)
  • K250468 — iSLEEVE Introducer Set (March 20, 2025)
  • K242950 — WallFlex Biliary PLUS RX Stent System (December 6, 2024)
  • K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (October 18, 2024)
  • K242507 — OBSIDIO™ Conformable Embolic (October 3, 2024)
  • K240464 — WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX (August 30, 2024)
  • K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (April 29, 2024)
  • K234002 — ICEfx Cryoablation System (FPRCH8000-02) (March 13, 2024)

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)
  • 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)
  • K903529 — BML SERIES (January 23, 1991)
  • K902170 — SOEHENDRA LITHOTRIPSY SET (July 25, 1990)
  • K860863 — ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER (May 15, 1986)

FDA data resources