Ureteral Bulb Dilators

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K873178 ↗

FDA Product Code

EZN

Device Class

Class II

Regulation

21 CFR Part 876.5470

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

• 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

• Gastrointestinal Tube

  Class II

  FDA 510(k) K870508 Active Cleared 11 May 1987

See all devices from Penn Medical Devices, Inc. →