BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK— 510(k) K061307
Substantially EquivalentAaron Medical Industries
FDA 510(k) clearance K061307 for BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK, Substantially Equivalent on 2006-07-18. Applicant: Aaron Medical Industries. Device class: 2.
Clearance details
- Applicant
- Aaron Medical Industries
- 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 Aaron Medical Industries
view all- K062337 — MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR
- K060117 — BOVIE BUTTON REMOTE HAND SWITCH
- K022856 — BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
- K021817 — AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V
- K020579 — AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03
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.