ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES— 510(k) K081398
Substantially EquivalentAdvanced Medical Innovations, Inc.
FDA 510(k) clearance K081398 for ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES, Substantially Equivalent on 2009-02-06. Applicant: Advanced Medical Innovations, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Medical Innovations, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
Recent devices under product code GEI
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.