Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)
Endolumik
ENDOLUMIK
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3026671998 | 3026671998 | ENDOLUMIK | 1 | N | 2026-01-01 | 364 Patteson Dr. #293 Morgantown WV US 26505 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 315294 | 1811154553 | K240069 | Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) | KNT | 2024-02-08 |
| 315294 | 1228626990 | K222880 | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) | KNT | 2023-03-03 |
| 315294 | 1528902439 | ||||
| 315294 | 1686679648 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KNT | 2 | 2024-02-08 |