K213818 is an FDA 510(k) clearance for the VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula, a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on June 27, 2022, 202 days after receiving the submission on December 7, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K213818 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 07, 2021 |
| Decision Date | June 27, 2022 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GCJ — Laparoscope, General & Plastic Surgery |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |