Device type

Laparoscope, General & Plastic Surgery, Reprocessed

Product code NLM · Class II · 21 CFR 876.1500 · Gastroenterology, Urology

The "Endoscope and accessories, reprocessed" is intended to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. 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).

FDA classification database