K895579
Substantially Equivalent for Some IndicationsPOLYSORB SYNTHETIC ABSORBABLE SUTURE
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Product code
- GAN
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Norwalk, CT, US
Adverse events under product code GAN
product code GAN- Injury
- 599
- Malfunction
- 1,658
- Total
- 2,257
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.