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510(k) K872389

PRECISION SCREW DRIVER SET by Med-Tool, Inc. — Product Code HXX

K872389 is an FDA 510(k) premarket notification submitted by Med-Tool, Inc. for the device "PRECISION SCREW DRIVER SET". The FDA issued a decision of Substantially Equivalent on July 15, 1987. The device falls under product code HXX (Screwdriver), a Class I device regulated under 21 CFR 888.4540. Med-Tool, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1987
Date Received
June 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screwdriver
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Med-Tool, Inc.

  • K874356 — PIN PUNCH (November 23, 1987)
  • K874357 — TAPERED PUNCH (November 23, 1987)
  • K874358 — COMBINATION WRENCHES (November 23, 1987)
  • K874359 — ADJUSTABLE 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)
  • K872384 — SIDE CUTTING PARALLEL ACTION PLIERS (July 2, 1987)
  • K872386 — C CLAMP (July 2, 1987)
  • K864019 — NEEDLE NOSE PLIERS (October 30, 1986)

Other clearances for product code HXX

  • K901166 — DALTON TECHNOLOGY FLEXIBLE SCREWDRIVER (June 13, 1990)
  • K873066 — ACROMED SCREW DRIVER (September 2, 1987)
  • K862689 — 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP (September 2, 1986)

FDA data resources