K132629 is an FDA 510(k) clearance for the REPROCESSED DILATING TIP TROCARS. This device is classified as a Laparoscope, General & Plastic Surgery, Reprocessed (Class II - Special Controls, product code NLM).
Submitted by Stryker Sustainability Solutions (Tempe, US). The FDA issued a Cleared decision on December 31, 2013, 131 days after receiving the submission on August 22, 2013.
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 | K132629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2013 |
| Decision Date | December 31, 2013 |
| Days to Decision | 131 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). |