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510(k) K854327

SUBCUTANEOUS TUNNELING NEEDLES & HANDLES by Concord Laboratories, Inc. — Product Code GCB

K854327 is an FDA 510(k) premarket notification submitted by Concord Laboratories, Inc. for the device "SUBCUTANEOUS TUNNELING NEEDLES & HANDLES". The FDA issued a decision of Substantially Equivalent on November 13, 1985. The device falls under product code GCB (Needle, Catheter), a Class I device regulated under 21 CFR 878.4200. Concord Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1985
Date Received
October 28, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Concord Laboratories, Inc.

  • K883840 — DRI-VENT ARTERIAL BLOOD SAMPLING KIT (May 16, 1989)
  • K871825 — MECONIUM SUCTION CATHETER (June 29, 1987)
  • K864535 — TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 (January 6, 1987)
  • K862039 — CONCORD CARE TRAY (July 3, 1986)
  • K854601 — SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH (January 10, 1986)
  • K851134 — REGIONAL ANESTHESIA TRAYS (July 15, 1985)
  • K842095 — EPIDURAL TRAYS (July 3, 1984)
  • K841486 — ARTERIAL BLOOD SAMPLING KITS (May 23, 1984)
  • K840987 — VAPORIZED HEPARIN (April 5, 1984)
  • K840986 — PREFILLED PULSATOR SYRINGE (April 5, 1984)

Other clearances for product code GCB

  • K150800 — Valved Safety Centesis Catheter (November 12, 2015)
  • K974146 — PARACENTESIS CATHETER DEVICE (January 28, 1998)
  • K930568 — ADAIR/VERESS NEEDLE INTRODUCER SET (July 22, 1993)
  • K923028 — TURKEL PNEUMOTHORAX KIT (August 4, 1992)
  • K900374 — ADAIR/VERESS NEEDLE INTRODUCER SET (April 20, 1990)
  • K852428 — MANAN EPIDURAL NEEDLE (June 27, 1985)
  • K780896 — NEEDLES, DESIGN CHANGE, IV CATHETERS (August 23, 1978)

FDA data resources