Laparoscopic Accessories, Esophageal Sizing
The Laparoscopic Accessories, Esophageal Sizing is a Class 2 gastroenterology device intended to laparoscopically measure an extraluminal dimensional parameter of a gastrointestinal organ, used to assist in surgical planning and implant sizing during laparoscopic procedures. It requires 510(k) clearance and is regulated under 21 CFR 876.5360 within the Gastroenterology and Urology medical specialty. The product code is QJN. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QJN
- Device Class
- FDA class 2
- Regulation Number
- 876.5360
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
To laparoscopically measure an extraluminal dimensional parameter of a gastrointestinal organ.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.