K111002 is an FDA 510(k) clearance for the REPROCESSED ENDOSCOPIC TROCARS. This device is classified as a Laparoscope, General & Plastic Surgery, Reprocessed (Class II - Special Controls, product code NLM).
Submitted by Sterilmed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on July 18, 2011, 98 days after receiving the submission on April 11, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. 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)..
| 510(k) Number | K111002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2011 |
| Decision Date | July 18, 2011 |
| Days to Decision | 98 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). |