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FDA 510(k)

Standard Bougie, 38 Fr. and Hand Pump

K-Number: K212728 · 2021-09-23

ApplicantStandard Bariatrics
Decision Date2021-09-23
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Standard Bariatrics. The 510(k) number is K212728.

When was Standard Bougie, 38 Fr. and Hand Pump approved by the FDA?

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

What company makes Standard Bougie, 38 Fr. and Hand Pump?

Standard Bougie, 38 Fr. and Hand Pump is manufactured by Standard Bariatrics.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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