A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES— 510(k) K915300
Substantially EquivalentAlto Development Corp.
FDA 510(k) clearance K915300 for A & EM MEDICAL ELECTROSURGICAL PENCIL/ACCESSORIES, Substantially Equivalent on 1992-02-18. Applicant: Alto Development Corp.. Device class: 2.
Clearance details
- Applicant
- Alto Development Corp.
- 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
- Farmingdale, NJ, US
Recent devices under product code GEI
view allMore clearances from Alto Development Corp.
view all- K964621 — A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON
- K932513 — LABELING FOR MYO/WIRE II STERNOTOMY SUTURES
- K931537 — A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT
- K930528 — A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS
- K914193 — A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT
Adverse 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.