NLRClass II
Unit, Electrosurgical, Endoscopic (with Or Without Accessories), Reprocessed
Gastroenterology, Urology · 21 CFR 876.4300
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).
MDR events2All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances1All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Malfunction2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
1 clearances for this product code