MEG LAPAROSCOPIC ELECTRODES— 510(k) K081431
Substantially EquivalentBovie Medical
FDA 510(k) clearance K081431 for MEG LAPAROSCOPIC ELECTRODES, Substantially Equivalent on 2008-07-24. Applicant: Bovie Medical. Device class: 2.
Clearance details
- Applicant
- Bovie Medical
- 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
- St. Petersburg, FL, US
Recent devices under product code GEI
view allMore clearances from Bovie Medical
view all- K092149 — BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215
- K091440 — LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L
- K090586 — BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC)
- K082568 — SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE
- K082109 — BOVIE ICON GENERAL PURPOSE RF GENERATOR
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.