ELECTROSCOPE MONITOR, EM-1— 510(k) K913625
Substantially EquivalentElectroscope, Inc.
FDA 510(k) clearance K913625 for ELECTROSCOPE MONITOR, EM-1, Substantially Equivalent on 1991-12-30. Applicant: Electroscope, Inc.. Device class: 2.
Clearance details
- Applicant
- Electroscope, 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
- Boulder, CO, US
Recent devices under product code GEI
view allMore clearances from Electroscope, Inc.
view all- K000480 — ACTIVE ELECTRODE MONITORING SYSTEM
- K972562 — BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED
- K973682 — BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT,
- K912780 — MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD
- K912781 — ELECTROSHIELD
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.