NERVE LOCATOR/STIMULATOR— 510(k) K905045
Substantially EquivalentAaron Medical Industries
FDA 510(k) clearance K905045 for NERVE LOCATOR/STIMULATOR, Substantially Equivalent on 1991-03-15. Applicant: Aaron Medical Industries. Device class: 2.
Clearance details
- Applicant
- Aaron Medical Industries
- Product code
- Code ETN
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Petersburg, FL, US
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More clearances from Aaron Medical Industries
view all- K062337 — MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR
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- 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 ETN
product code ETN- Death
- 7
- Injury
- 327
- Malfunction
- 2,776
- Total
- 3,110
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.