ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED)— 510(k) K080412
Substantially EquivalentShanghai Pudong Jinhuan Medical Products Co., Ltd.
FDA 510(k) clearance K080412 for ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED), Substantially Equivalent on 2008-09-04. Applicant: Shanghai Pudong Jinhuan Medical Products Co., Ltd..
Clearance details
- Applicant
- Shanghai Pudong Jinhuan Medical Products Co., Ltd.
- Product code
- Code GAM
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- La Mirada, CA, US
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.