Dantec 13L40 St. Marks's Pudendal Electrode

No FDA recalls on record, checked 12 Oct 2026.

510(k) Number

K874758 ↗

FDA Product Code

FAP

Device Class

Class II

Regulation

21 CFR Part 876.1620

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K872106 Active Cleared 10 Sep 1987

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  FDA 510(k) K894911 Active Cleared 14 May 1990

• Dantec Magnetic Stimulator

  Class II

  FDA 510(k) K881915 Active Cleared 17 Oct 1988

• 13L81 Disposable Sphincter Electrode, 13L33 Cable

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  FDA 510(k) K874759 Active Cleared 14 Apr 1988

• Dantec 22K60/61/62 Catheter Tip Transducer

  Class II

  FDA 510(k) K884915 Active Cleared 4 Oct 1989

• Urdyn 5000 (Uroflowmeter)

  Class I

  FDA 510(k) K860368 Active Cleared 23 Apr 1986

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