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510(k) K874535

MICROTEK MINI-MAX DRILL SYSTEM by Microtek Medical, Inc. — Product Code DZI

K874535 is an FDA 510(k) premarket notification submitted by Microtek Medical, Inc. for the device "MICROTEK MINI-MAX DRILL SYSTEM". The FDA issued a decision of Substantially Equivalent on November 23, 1987. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. Microtek Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1987
Date Received
November 3, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Bone, Powered
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by Microtek Medical, Inc.

  • K251676 — Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decan (September 16, 2025)
  • K110358 — VENODYNE V810 (May 5, 2011)
  • K102971 — FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK (February 23, 2011)
  • K062899 — MICROTEK MEDICAL SURGICAL GOWN/TOGA (January 25, 2007)
  • K060200 — MICROTEK MEDICAL WARMING DRAPE (May 31, 2006)
  • K050322 — MICROTEK EQUIPMENT DRAPES (May 17, 2005)
  • K022903 — CHILLBUSTER (November 27, 2002)
  • K020956 — VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA (May 16, 2002)
  • K011318 — VENODYNE DVT ADVANTAGE PLUS (October 25, 2001)
  • K001802 — VENODYNE DVT ADVANTAGE MODEL 610 (January 9, 2001)

Other clearances for product code DZI

  • K253655 — Angled Screwdriver MED (M-SD090) (July 31, 2026)
  • K253776 — Implantmed Plus II & Piezomed Plus II Module (June 18, 2026)
  • K254163 — VarioSurg 4 (December 23, 2025)
  • K242432 — MT-Bone (August 19, 2024)
  • K240340 — Surgical Drive System (Model: ES70, ES90, E8) (July 18, 2024)
  • K231087 — Guided Surgery Kit (August 16, 2023)
  • K192561 — TRAUS SUS20 (July 13, 2020)
  • K200265 — Surgical Drills (June 30, 2020)
  • K192033 — Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-In (June 9, 2020)
  • K172137 — PIEZOTOME CUBE (May 3, 2018)

FDA data resources