Penn 3-RING Handle

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K862729 ↗

FDA Product Code

FFL

Device Class

Class II

Regulation

21 CFR Part 876.4680

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

• Gastrointestinal Tube

  Class II

  FDA 510(k) K870508 Active Cleared 11 May 1987

See all devices from Penn Medical Devices, Inc. →

• What clinical specialties is the Penn 3-Ring Handle primarily used in, and how does it assist in procedures?

  The Penn 3-Ring Handle is designed for use in gastroenterology and urology settings. It is a ureteral stone basket with a three-ring mechanism, which helps securely grasp and dislodge ureteral stones during endoscopic procedures. This aids in removing calculi from the urinary tract efficiently.

• Is the Penn 3-Ring Handle intended for single-use or reusable applications, and what does this mean for maintenance?

  The Penn 3-Ring Handle is supplied as a reusable instrument, meaning it is meant to be cleaned, sterilized, and reused multiple times. This requires proper maintenance protocols, including cleaning, disinfection, and sterilization between uses to ensure safety and functionality.

• What regulatory pathway was followed for FDA clearance of the Penn 3-Ring Handle, and when was it approved?

  The Penn 3-Ring Handle received FDA 510(k) clearance under the product code FFL, classified under CFR Title 21, regulation number 876.4680. The device was determined to be substantially equivalent to a predicate and was cleared on October 24, 1986, following a traditional review process.

• Are there any specific storage or handling instructions mentioned for the Penn 3-Ring Handle?

  The provided regulatory data does not explicitly detail storage or handling instructions for the Penn 3-Ring Handle. However, as a reusable metal device, it should be stored in a clean, dry environment to prevent corrosion or damage. Proper cleaning and sterilization protocols should be followed as per manufacturer guidelines to maintain functionality and safety.