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510(k) K852143

HALL IRRIGATION SYSTEM by Hall Surgical, Division of Zimmer, Inc. — Product Code GBX

K852143 is an FDA 510(k) premarket notification submitted by Hall Surgical, Division of Zimmer, Inc. for the device "HALL IRRIGATION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 26, 1985. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200. Hall Surgical, Division of Zimmer, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1985
Date Received
May 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Hall Surgical, Division of Zimmer, Inc.

  • K942660 — HALL MICROCHOICE ELECTRIC POWERED SYSTEM (September 7, 1994)
  • K864734 — HALL ORAL IMPLANT SYSTEM (February 10, 1987)
  • K864929 — HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST (January 28, 1987)
  • K864163 — HALL DUNBAR DRILL GUIDE SYSTEM (November 20, 1986)
  • K862778 — HALL CANNLULA SYSTEM (September 8, 1986)
  • K862474 — HALL STERNUM SAW (July 17, 1986)
  • K862529 — HALL STERILE BUR (July 15, 1986)

Other clearances for product code GBX

  • K131659 — MOERAE VEIN PREPARATION KIT (March 3, 2014)
  • K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE (December 17, 2008)
  • K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (October 21, 2005)
  • K043515 — GRAFTSAVER (March 31, 2005)
  • K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P (January 10, 2002)
  • K000704 — DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (May 19, 2000)
  • K974233 — LYSONIX IRRIGATION SYSTEM (February 3, 1998)
  • K973703 — JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (December 4, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
  • K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR (March 10, 1997)

FDA data resources