QJN — Laparoscopic Accessories, Esophageal Sizing Class II
FDA product code QJN covers "Laparoscopic Accessories, Esophageal Sizing", a Class II medical device regulated under 21 CFR 876.5360. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QJN
- Device Class
- Class II
- Regulation Number
- 876.5360
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To laparoscopically measure an extraluminal dimensional parameter of a gastrointestinal organ.