MICROSURGICAL INSTRUMENTS— 510(k) K823174
Substantially EquivalentConcept, Inc.
FDA 510(k) clearance K823174 for MICROSURGICAL INSTRUMENTS, Substantially Equivalent on 1982-11-16. Applicant: Concept, Inc..
Clearance details
- Applicant
- Concept, Inc.
- Product code
- Code HNR
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Adverse events under product code HNR
product code HNR- Malfunction
- 497
- Other
- 1
- Total
- 498
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.