FDA 510(k)

Standard Bougie, 38 Fr. and Hand Pump

N.º K: K212728 · 2021-09-23

Fecha de decisión2021-09-23

Código de productoKNT

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Standard Bougie, 38 Fr. and Hand Pump is the device name listed in this FDA 510(k) record. The listed applicant is Standard Bariatrics. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K212728. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Standard Bougie, 38 Fr. and Hand Pump?

Standard Bougie, 38 Fr. and Hand Pump is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Standard Bariatrics. The 510(k) number is K212728.

When did Standard Bougie, 38 Fr. and Hand Pump receive FDA 510(k) clearance?

Standard Bougie, 38 Fr. and Hand Pump received FDA 510(k) clearance on 2021-09-23, under 510(k) number K212728.

Who is the listed applicant for Standard Bougie, 38 Fr. and Hand Pump?

The FDA 510(k) record lists Standard Bariatrics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Standard Bougie, 38 Fr. and Hand Pump?

The FDA product code for Standard Bougie, 38 Fr. and Hand Pump is KNT.

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Fuente oficial

Ver en la base de datos de la FDA →

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