NLT
- Product code
- NLT
- Device name
- Snare, Flexible, Reprocessed
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.4300
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
FDA classification definition
Intended to be used endoscopically to snare tissue in preparation for application of electrosurgical current. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Official FDA classification page: NLT
Classification and pathway per current FDA publications. Data from openFDA (CC0).