FDA Device Intelligence
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Catheter, Rectal

FDA product code GBT · Class 2 · Gastroenterology, Urology

13
Registered devices
14
Adverse events
1
Recalls
3
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2017-06-14Medspira, LlcPotential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.