Submission Details
| 510(k) Number | K201511 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 05, 2020 |
| Decision Date | July 31, 2020 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
Reprocessed Endoscopic Trocars and Sleeves
Jul 2020
Decision
56d
Days
Class 2
Risk
About This 510(k) Submission
K201511 is an FDA 510(k) clearance for the Reprocessed Endoscopic Trocars and Sleeves, 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 July 31, 2020, 56 days after receiving the submission on June 5, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.
Device Classification
| 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). |
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