K223709 is an FDA 510(k) clearance for the Kyphoplasty Balloon Catheter. This device is classified as a Arthroscope (Class II - Special Controls, product code HRX).
Submitted by Jiangsu Changmei Medtech Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on August 16, 2023, 247 days after receiving the submission on December 12, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.1100. 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 | K223709 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2022 |
| Decision Date | August 16, 2023 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRX - Arthroscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.1100 |
| 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). |