Submission Details
| 510(k) Number | K241434 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 21, 2024 |
| Decision Date | October 04, 2024 |
| Days to Decision | 136 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
Cleared
Special
Video Ureteroscope System
Oct 2024
Decision
136d
Days
Class 2
Risk
About This 510(k) Submission
K241434 is an FDA 510(k) clearance for the Video Ureteroscope System, a Ureteroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FGB), submitted by Hunan Vathin Medical Instrument Co., Ltd. (Xingtan, CN). The FDA issued a Cleared decision on October 4, 2024, 136 days after receiving the submission on May 21, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
Device Classification
| Product Code | FGB — Ureteroscope And Accessories, Flexible/rigid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |
Manufacturer
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