UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece— 510(k) K200318
Substantially EquivalentKARL STORZ Endoscopy-America, Inc.
FDA 510(k) clearance K200318 for UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece, Substantially Equivalent on 2020-10-22. Applicant: KARL STORZ Endoscopy-America, Inc..
Clearance details
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Product code
- Code ERL
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- El Segundo, CA, US
Adverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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.