KEISEI HANDLES FOR SURGICAL BLADES— 510(k) K863212
Substantially EquivalentKeisei Medical Industrial Co., Ltd.
FDA 510(k) clearance K863212 for KEISEI HANDLES FOR SURGICAL BLADES, Substantially Equivalent on 1986-09-02. Applicant: Keisei Medical Industrial Co., Ltd..
Clearance details
- Applicant
- Keisei Medical Industrial Co., Ltd.
- Product code
- Code GDZ
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethel, CT, US
Adverse events under product code GDZ
product code GDZ- Other
- 1
- Total
- 1
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.