Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
NLR · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.4300
Classification
FDA Product Code
NLR
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 876.4300
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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).