K250483 is an FDA 510(k) clearance for the PhotonBlade 3. This device is classified as a Electrosurgical, Cutting & Coagulation & Accessories (Class II - Special Controls, product code GEI).
Submitted by Stryker Instruments (Portage, US). The FDA issued a Cleared decision on September 9, 2025, 202 days after receiving the submission on February 19, 2025.
This device falls under the Cardiovascular 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 | K250483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2025 |
| Decision Date | September 09, 2025 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| 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). |