Recognized standard
F1828-22
FDA recognition 9-151 · ASTM · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-151 |
|---|---|
| Designation | F1828-22 |
| Title | Standard Specification for Ureteral Stents |
| Standards developer | ASTM International |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | May 26, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification covers the referee test methods for evaluating the performance characteristics of a single-use ureteral stent with retaining means at both ends, during short-term use for drainage of urine from the kidney to the bladder. These stents are typically available in diameters of 3.7… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: