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510(k) K911477

LAPAROSCOPIC BASKET FLEXIBLE AND RIGID by United States Endoscopy Group, Inc. — Product Code LQC

K911477 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "LAPAROSCOPIC BASKET FLEXIBLE AND RIGID". The FDA issued a decision of Substantially Equivalent on August 14, 1991. The device falls under product code LQC (Lithotriptor, Biliary Mechanical), a Class II device regulated under 21 CFR 876.4500. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1991
Date Received
April 4, 1991
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 United States Endoscopy Group, Inc.

  • K192265 — gi-4000 Electrosurgical Generator (May 21, 2020)
  • K200745 — Lariat, Hot/Cold Snare (April 21, 2020)
  • K192059 — Bio Guard Air/Water & Suction Valves (September 17, 2019)
  • K191559 — AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIF (August 1, 2019)
  • K182909 — Roth Net Retriever Product Line (November 21, 2018)
  • K182258 — AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - (September 21, 2018)
  • K173650 — AquaShield System CO2- Fujifilm (January 5, 2018)
  • K172805 — gi-4000 Electrosurgical Generator (October 23, 2017)
  • K163495 — AdvanCE capsule endoscope delivery device (March 10, 2017)
  • K163492 — Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex (January 6, 2017)

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)
  • 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