Penn & Olympus Ureteroscopy Guide Sheath & Dilator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K862107 ↗

FDA Product Code

ODC

Device Class

Class II

Regulation

21 CFR Part 876.1500

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

• 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

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