Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
FDA product code NLR · Class II (moderate risk) · 21 CFR 876.4300 · Gastroenterology, Urology
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).
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Medisiss 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K030919 | Siss, Inc. (D.B.A.Medisiss) Reprocessd Electrosurgical Instruments and AccessoriesNLR · Traditional | Medisiss | 07/03/2003SE |