Home / 510(k) Clearances / K872387

510(k) K872387

STANDARD SCREW DRIVER by Med-Tool, Inc. — Product Code LRZ

K872387 is an FDA 510(k) premarket notification submitted by Med-Tool, Inc. for the device "STANDARD SCREW DRIVER". The FDA issued a decision of Substantially Equivalent on July 16, 1987. The device falls under product code LRZ (Screwdriver, 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
July 16, 1987
Date Received
June 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screwdriver, 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)
  • 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)
  • K864018 — HACKSAW (October 30, 1986)

Other clearances for product code LRZ

  • K896589 — MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP (December 27, 1989)
  • K872490 — 1.1 SCREWDRIVERS (July 23, 1987)

FDA data resources