GEJ
- Product code
- GEJ
- Device name
- Carrier, Ligature
- Device class
- Class 1
- 21 CFR
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 5 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240185 | 2024-05-03 | Cypris Medical | Cypris eXact Suture Placement Device |
Official FDA classification page: GEJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).