POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP— 510(k) K001185

Substantially Equivalent for Some Indications

Cp Medical

FDA 510(k) clearance K001185 for POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP, Substantially Equivalent for Some Indications on 2000-06-23. Applicant: Cp Medical.

Clearance details

Applicant
Cp Medical
Product code
Code GAW
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent for Some Indications
Clearance type
Traditional
Location
Portland, OR, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GAW

product code GAW
Death
66
Injury
1,616
Malfunction
10,428
Total
12,110

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.