K233493 is an FDA 510(k) clearance for the Tricera Arthroscopic System. This device is classified as a Electrosurgical, Cutting & Coagulation & Accessories (Class II - Special Controls, product code GEI).
Submitted by Relign Corporation (Campbell, US). The FDA issued a Cleared decision on November 28, 2023, 29 days after receiving the submission on October 30, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4400. 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)..
| 510(k) Number | K233493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2023 |
| Decision Date | November 28, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | GEI - Electrosurgical, Cutting & Coagulation & Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| 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). |