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510(k) K861953

PARALLEL ACTION PLIERS by Med-Tool, Inc. — Product Code HTC

K861953 is an FDA 510(k) premarket notification submitted by Med-Tool, Inc. for the device "PARALLEL ACTION PLIERS". The FDA issued a decision of Substantially Equivalent on June 6, 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
June 6, 1986
Date Received
May 20, 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.

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

Other clearances for product code HTC

  • K872384 — SIDE CUTTING PARALLEL ACTION PLIERS (July 2, 1987)
  • K864019 — NEEDLE NOSE PLIERS (October 30, 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)
  • K840980 — HALF ROUND FILE (April 25, 1984)
  • K840978 — TOGGLE LOCKING PLIER (April 25, 1984)
  • K830721 — WIRE TWISTERS (April 12, 1983)

FDA data resources