HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP— 510(k) K945764
Substantially EquivalentAaron Medical Industries
FDA 510(k) clearance K945764 for HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP, Substantially Equivalent on 1995-01-30. Applicant: Aaron Medical Industries. Device class: 2.
Clearance details
- Applicant
- Aaron Medical Industries
- Product code
- Code KNS
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Petersburg, FL, US
Recent devices under product code KNS
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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 KNS
product code KNS- Death
- 44
- Injury
- 2,361
- Malfunction
- 4,771
- Total
- 7,176
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.