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510(k) K992843

THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F by Ohio Medical Instrument Co., Inc. — Product Code HAW

K992843 is an FDA 510(k) premarket notification submitted by Ohio Medical Instrument Co., Inc. for the device "THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F". The FDA issued a decision of Substantially Equivalent on November 2, 1999. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Ohio Medical Instrument Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1999
Date Received
August 24, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

Other clearances by Ohio Medical Instrument Co., Inc.

  • K021604 — MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 (July 29, 2002)
  • K013428 — MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM (April 4, 2002)
  • K991267 — SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYST (July 12, 1999)
  • K983282 — OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 (November 19, 1998)
  • K982244 — MAYFIELD ACCISS OPTICAL SYSTEM (September 23, 1998)
  • K960807 — TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 (May 17, 1996)
  • K953124 — MAYFIELD RADIOLUCENT 2000 SKULL CLAMP (February 9, 1996)
  • K941558 — MAYFIELD CHILD DISPOSABLE SKULL PIN (December 6, 1995)
  • K934289 — MAYFIELD RADIOLUCENT SKULL CLAMP (January 7, 1994)
  • K932807 — MAYFIELD* A-2000 SKULL CLAMP (September 28, 1993)

Other clearances for product code HAW

  • K253663 — Zeta Navigation System (May 1, 2026)
  • K253379 — Stealth AXiS Cranial clinical application (March 26, 2026)
  • K231897 — NeuroAlign software (October 21, 2025)
  • K251317 — SOLOPASS 2.0 System (September 5, 2025)
  • K250893 — Ball Joint Guide Array (66295) (September 4, 2025)
  • K250505 — EZ-FIDUCIALS (July 9, 2025)
  • K242575 — Stereotaxic Guiding Surgical Devices, NaoTrac S (May 23, 2025)
  • K241327 — Navient Image Guide Navigation System (955-NC-NC), Cranial (February 5, 2025)
  • K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignm (January 28, 2025)
  • K243657 — ClearPoint System (Software Version 3.0) (January 24, 2025)

FDA data resources