Holycon Synthetic Absorbable Sutures— 510(k) K173043
Substantially EquivalentNantong Holycon Medical Devices Co., Ltd.
FDA 510(k) clearance K173043 for Holycon Synthetic Absorbable Sutures, Substantially Equivalent on 2017-12-14. Applicant: Nantong Holycon Medical Devices Co., Ltd..
Clearance details
- Applicant
- Nantong Holycon Medical Devices Co., Ltd.
- Product code
- Code GAM
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nantong, CN
Adverse events under product code GAM
product code GAM- Death
- 45
- Injury
- 5,711
- Malfunction
- 30,744
- Other
- 4
- Total
- 36,504
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.