Submission Details
| 510(k) Number | K252176 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 11, 2025 |
| Decision Date | August 08, 2025 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Special
Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
Aug 2025
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K252176 is an FDA 510(k) clearance for the Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS), a Cystoscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FAJ), submitted by Guangzhou Red Pine Medical Instrument Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on August 8, 2025, 28 days after receiving the submission on July 11, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
Device Classification
| Product Code | FAJ — Cystoscope And Accessories, Flexible/rigid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Examine And Perform 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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