Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring Device with Stop Valve, Amy Bae

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K973893 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Gastrointestinal Tubes & Accessories

  Class II

  FDA 510(k) K945618 Active Cleared 12 Oct 1995

• Background Suction Matt

  Class I

  FDA 510(k) K895727 Active Cleared 24 Oct 1989

• Vessel Occluder

  Class I

  FDA 510(k) K895726 Active Cleared 24 Oct 1989

• Stoma Measuring Device

  Class II

  FDA 510(k) K923692 Active Cleared 7 May 1993

• One Step Button(Tm)

  Class II

  FDA 510(k) K910584 Active Cleared 23 May 1991

• Vessel Loops

  Class I

  FDA 510(k) K895682 Active Cleared 24 Oct 1989

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