Coons Soft Stent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K830483 ↗

FDA Product Code

FGE

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Hypodermic Needles & Syringes

  Class I

  FDA 510(k) K821348 Active Cleared 10 Jun 1982

• Medi-Tech Dilatation Catheters

  Class II

  FDA 510(k) K843383 Active Cleared 24 Oct 1984

• Catheter, External Male Nursing Care

  Class II

  FDA 510(k) K781780 Active Cleared 7 Dec 1978

• Catheter, Transluminal Balloon

  Class I

  FDA 510(k) K781772 Active Cleared 6 Mar 1979

• Enter-A1 Enteric Feeding Tube

  Class II

  FDA 510(k) K812279 Active Cleared 25 Aug 1981

• Coagulation Reference Plasma, Abnormal

  Class II

  FDA 510(k) K904073 Active Cleared 22 Oct 1990

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