FDA Product Code NLM: Laparoscope, General & Plastic Surgery, Reprocessed

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).

Leading manufacturers include Sterilmed, Inc., Vanguard Medical Concepts, Inc. and Stryker Sustainability Solutions.