NLR — Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed Class II
FDA product code NLR covers "Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed", a Class II medical device regulated under 21 CFR 876.4300. 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
- NLR
- Device Class
- Class II
- Regulation Number
- 876.4300
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K030919 | medisiss | SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORI | July 3, 2003 |