CIVCO STEPPER— 510(k) K871413
Substantially EquivalentCIVCO Medical Instruments Co., Inc.
FDA 510(k) clearance K871413 for CIVCO STEPPER, Substantially Equivalent on 1987-07-14. Applicant: CIVCO Medical Instruments Co., Inc..
Clearance details
- Applicant
- CIVCO Medical Instruments Co., Inc.
- Product code
- Code FZX
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalona, IA, US
Adverse events under product code FZX
product code FZX- Injury
- 797
- Malfunction
- 3,815
- Total
- 4,612
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.