XBraid TT Suture Tape— 510(k) K162310
Substantially EquivalentStryker
FDA 510(k) clearance K162310 for XBraid TT Suture Tape, Substantially Equivalent on 2016-11-10. Applicant: Stryker. Device class: 2.
Clearance details
- Applicant
- Stryker
- 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
- Greenwood Village, CO, US
Recent devices under product code GAT
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- K230754 — L12 LED Light Source with AIM
- K230605 — 1788 4K Camera System with Advanced Imaging Modality
- K230216 — 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)
Adverse 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.