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510(k) K911364

SPOON FORCEPS, 11MM by Northgate Technologies, Inc. — Product Code LQC

K911364 is an FDA 510(k) premarket notification submitted by Northgate Technologies, Inc. for the device "SPOON FORCEPS, 11MM". The FDA issued a decision of Substantially Equivalent on October 23, 1991. The device falls under product code LQC (Lithotriptor, Biliary Mechanical), a Class II device regulated under 21 CFR 876.4500. Northgate Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1991
Date Received
March 28, 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 Northgate Technologies, Inc.

  • K202813 — URO-TOUCH 9 French Probe (June 14, 2021)
  • K202944 — NEBULAE SRS Laparoscopic Surgical Smoke Removal System (March 25, 2021)
  • K130368 — AUTOLITH TOUCH; URO TOUCH (November 15, 2013)
  • K120151 — NEBULAE I (August 17, 2012)
  • K041560 — FLO-ASSISTANT (September 28, 2004)
  • K033614 — MISTIC HUMIDIFICATION SYSTEM 850-00/0 (July 29, 2004)
  • K022052 — 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 (January 24, 2003)
  • K010053 — HUMI-FLOW, MODEL 6-850-00/ 01/02 (October 23, 2001)
  • K011928 — HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 (August 10, 2001)
  • K001325 — FLO ASSISTANT, MODEL 4-250-00 (August 18, 2000)

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)
  • 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