K060676 is an FDA 510(k) clearance for the NES REPROCESSED ENDOSCOPIC TROCAR, a Laparoscope, General & Plastic Surgery, Reprocessed (Class II — Special Controls, product code NLM), submitted by Northeast Scientific, Inc. (Waterbury, US). The FDA issued a Cleared decision on September 7, 2007, 542 days after receiving the submission on March 14, 2006. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K060676 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 14, 2006 |
| Decision Date | September 07, 2007 |
| Days to Decision | 542 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NLM — Laparoscope, General & Plastic Surgery, Reprocessed |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | 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). |