SINUSCOPE AND BACCESSORIES— 510(k) K002214
Substantially EquivalentPollux Endoscopy, Inc.
FDA 510(k) clearance K002214 for SINUSCOPE AND BACCESSORIES, Substantially Equivalent on 2000-11-21. Applicant: Pollux Endoscopy, Inc..
Clearance details
- Applicant
- Pollux Endoscopy, Inc.
- Product code
- Code EOB
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plant City, FL, US
Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
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.