QTH — Endoscopic Light-Projecting Measuring Device Class II
FDA product code QTH covers "Endoscopic Light-Projecting Measuring Device", a Class II medical device regulated under 21 CFR 876.1530. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QTH
- Device Class
- Class II
- Regulation Number
- 876.1530
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN210032 | rqmis | AccuMeasure System | July 26, 2022 |