AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE— 510(k) K000961
Substantially EquivalentAaron Medical Industries
FDA 510(k) clearance K000961 for AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE, Substantially Equivalent on 2000-04-19. 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
- Special
- 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
- K061307 — BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK
- 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
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.