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Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed

FDA product code NLR · 1 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.4300
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2003-07-03 – 2003-07-03

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).

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