NLR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- This device is intended to be used endoscopically to remove tissue and control bleeding by use of high frequency electrical 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).
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES (K030919) | Medisiss | 2003-07-03 |
Track NLR automatically
Every clearance here is in the API, with alerts when new ones post.