StacksVerified U.S. regulatory reference

21 CFR §876.4630

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. Ureteral stent accessories aid in the insertion of the ureteral stent that is placed into the ureter to provide ureteral rigidity and allow the passage of urine. This generic type of device includes the stent positioner, wire guide, and pigtail straightener.
  2. (b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.