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510(k) K864019

NEEDLE NOSE PLIERS by Med-Tool, Inc. — Product Code HTC

K864019 is an FDA 510(k) premarket notification submitted by Med-Tool, Inc. for the device "NEEDLE NOSE PLIERS". The FDA issued a decision of Substantially Equivalent on October 30, 1986. The device falls under product code HTC (Pliers, Surgical), a Class I device regulated under 21 CFR 878.4800. Med-Tool, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1986
Date Received
October 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pliers, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Med-Tool, Inc.

  • K874357 — TAPERED PUNCH (November 23, 1987)
  • K874356 — PIN PUNCH (November 23, 1987)
  • K874359 — ADJUSTABLE WRENCHES (November 23, 1987)
  • K874358 — COMBINATION WRENCHES (November 23, 1987)
  • K872388 — NAIL SET (July 23, 1987)
  • K872385 — VICE OR BENCH VICE (July 16, 1987)
  • K872387 — STANDARD SCREW DRIVER (July 16, 1987)
  • K872389 — PRECISION SCREW DRIVER SET (July 15, 1987)
  • K872386 — C CLAMP (July 2, 1987)
  • K872384 — SIDE CUTTING PARALLEL ACTION PLIERS (July 2, 1987)

Other clearances for product code HTC

  • K872384 — SIDE CUTTING PARALLEL ACTION PLIERS (July 2, 1987)
  • K861953 — PARALLEL ACTION PLIERS (June 6, 1986)
  • K854390 — WIRE CUTTING PLIERS OR LINEMAN'S PLIERS (November 19, 1985)
  • K844600 — SLIP JOINT PLIERS (December 14, 1984)
  • K844146 — TOGGLE LOCKING PLIERS-STRAIGHT JAW, CURVED JAW (November 20, 1984)
  • K840979 — SLIP JOINT PLIER (April 25, 1984)
  • K840978 — TOGGLE LOCKING PLIER (April 25, 1984)
  • K840980 — HALF ROUND FILE (April 25, 1984)
  • K830721 — WIRE TWISTERS (April 12, 1983)

FDA data resources