MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM— 510(k) K013428
Substantially EquivalentOhio Medical Instrument Co., Inc.
FDA 510(k) clearance K013428 for MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM, Substantially Equivalent on 2002-04-04. Applicant: Ohio Medical Instrument Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Ohio Medical Instrument Co., Inc.
- Product code
- Code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wrentham, MA, US
Recent devices under product code HAW
view allMore clearances from Ohio Medical Instrument Co., Inc.
view all- K021604 — MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
- K992843 — THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F
- K991267 — SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A
- K983282 — OMI OCCIPITAL CERVICAL LOOP, MODEL A1089
- K982244 — MAYFIELD ACCISS OPTICAL SYSTEM
Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.