Product code HCF— General, Plastic Surgery
Edwards Suture Fastening System
- Classification name
- Instrument, Ligature Passing And Knot Tying
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 5
- First cleared
- Most recent
Market context for product code HCF
FDA has cleared devices under product code HCF between 1979 and 2015, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2015
- 1993
- 1985
- 1984
- 1979
Top applicants under product code HCF
Adverse events under product code HCF
product code HCF- Death
- 6
- Other
- 1
- Total
- 7
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 →
Recent clearances under product code HCF
Data sourced from openFDA. This site is unofficial and independent of the FDA.