K212407 is an FDA 510(k) clearance for the Gastric Lightguide (GLG). This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Naser Dib Gabinet Lekarksi Nasmed (Warszawa, PL). The FDA issued a Cleared decision on July 26, 2022, 357 days after receiving the submission on August 3, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K212407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2021 |
| Decision Date | July 26, 2022 |
| Days to Decision | 357 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT - Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |