K250124 is an FDA 510(k) clearance for the Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532). This device is classified as a Laparoscope, General & Plastic Surgery (Class II - Special Controls, product code GCJ).
Submitted by Hangzhou Viction Medical Technology Co.,Ltd (Hangzhou, CN). The FDA issued a Cleared decision on August 6, 2025, 201 days after receiving the submission on January 17, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. 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 | K250124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2025 |
| Decision Date | August 06, 2025 |
| Days to Decision | 201 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). |