Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures +4 more— 510(k) K181774
Substantially EquivalentTeleflex Medical Incorporated
FDA 510(k) clearance K181774 for Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures +4 more, Substantially Equivalent on 2018-10-10. Applicant: Teleflex Medical Incorporated. Device class: 2.
Clearance details
- Device name as filed
- Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture
- Applicant
- Teleflex Medical Incorporated
- Product code
- Code GAT
- Device class
- Class 2
- Regulation
- 21 CFR 878.5000
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Recent devices under product code GAT
view allMore clearances from Teleflex Medical Incorporated
view allAdverse events under product code GAT
product code GAT- Death
- 19
- Injury
- 4,163
- Malfunction
- 8,646
- Other
- 2
- Total
- 12,830
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.