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510(k) K860863

ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER by George Percy Mcgown — Product Code LQC

K860863 is an FDA 510(k) premarket notification submitted by George Percy Mcgown for the device "ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER". The FDA issued a decision of Substantially Equivalent on May 15, 1986. The device falls under product code LQC (Lithotriptor, Biliary Mechanical), a Class II device regulated under 21 CFR 876.4500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1986
Date Received
March 7, 1986
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 for product code LQC

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  • 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)
  • K903529 — BML SERIES (January 23, 1991)
  • K902170 — SOEHENDRA LITHOTRIPSY SET (July 25, 1990)

FDA data resources