Ureteral Stent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K871667 ↗

FDA Product Code

FAD

Device Class

Class II

Regulation

21 CFR Part 876.4620

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Devine (Suprapubic Sound and Guide)

  Class II

  FDA 510(k) K873177 Active Cleared 14 Oct 1987

• Rorertazzi Nasopharyngeal Airway

  Class I

  FDA 510(k) K873949 Active Cleared 20 Oct 1987

• Ureteral Bulb Dilators

  Class II

  FDA 510(k) K873178 Active Cleared 30 Sep 1987

• Penn & Olympus Ureteroscopy Guide Sheath & Dilator

  Class II

  FDA 510(k) K862107 Active Cleared 11 Sep 1986

• Huffman Biopsy Unit

  Class I

  FDA 510(k) K873176 Active Cleared 14 Oct 1987

• Penn 3-RING Handle

  Class II

  FDA 510(k) K862729 Active Cleared 24 Oct 1986

See all devices from Penn Medical Devices, Inc. →

• What is the Ureteral Stent used for?

  The Ureteral Stent is used to maintain ureteral patency in patients with obstruction or following urological procedures, such as stone treatment, surgery, or trauma, by bridging a ureteral obstruction or holding the ureter open.

• How is the Ureteral Stent supplied?

  The Ureteral Stent is supplied under FDA product code FAD by Penn Medical Devices, Inc.

• Is the Ureteral Stent a single-use device?

  The description does not explicitly state whether the Ureteral Stent is for single-use or reuse, but it is typically used for a specific medical procedure and then removed.

• What is the regulatory status of the Ureteral Stent?

  The Ureteral Stent has been cleared with FDA 510(k) number K871667, indicating that it is substantially equivalent to a predicate device.