IntelliSense Drill— 510(k) K143191
Substantially EquivalentMcginley Innovations
FDA 510(k) clearance K143191 for IntelliSense Drill, Substantially Equivalent on 2015-02-20. Applicant: Mcginley Innovations. Device class: 1.
Clearance details
- Applicant
- Mcginley Innovations
- Product code
- Code HWE
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Casper, WY, US
Recent devices under product code HWE
view all- K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES
- K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
- K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
- K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
- K022744 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
Adverse events under product code HWE
product code HWE- Death
- 4
- Injury
- 448
- Malfunction
- 19,856
- Other
- 2
- Total
- 20,310
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.