Home / 510(k) Clearances / K844145

510(k) K844145

GENERAL SURGICAL FILES by Med-Tool, Inc. — Product Code GEO

K844145 is an FDA 510(k) premarket notification submitted by Med-Tool, Inc. for the device "GENERAL SURGICAL FILES". The FDA issued a decision of Substantially Equivalent on November 20, 1984. The device falls under product code GEO (File, Surgical, General & Plastic Surgery), 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
November 20, 1984
Date Received
October 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
File, Surgical, General & Plastic Surgery
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 GEO

  • K830675 — ORAL SPONGE (March 24, 1983)

FDA data resources