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FDA 510(k)

Standard Tapered Bougie, 38 Fr.

K-Number: K222085 · 2022-10-31

ApplicantStandard Bariatrics, Inc.
Decision Date2022-10-31
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Standard Tapered Bougie, 38 Fr. is a medical device manufactured by Standard Bariatrics, Inc.. It received FDA 510(k) clearance on 2022-10-31 under approval number K222085. 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 Tapered Bougie, 38 Fr.?

Standard Tapered Bougie, 38 Fr. is a medical device that received FDA 510(k) clearance on 2022-10-31. It is manufactured by Standard Bariatrics, Inc.. The 510(k) number is K222085.

When was Standard Tapered Bougie, 38 Fr. approved by the FDA?

Standard Tapered Bougie, 38 Fr. received FDA 510(k) clearance on 2022-10-31, under approval number K222085.

What company makes Standard Tapered Bougie, 38 Fr.?

Standard Tapered Bougie, 38 Fr. is manufactured by Standard Bariatrics, Inc..

What is the FDA product code for Standard Tapered Bougie, 38 Fr.?

The FDA product code for Standard Tapered Bougie, 38 Fr. is KNT.

Related Clinical Trials

NCT07511998 A Randomized, Comparative, Controlled Study of Differences in the Incidence of Postoperative Sore Throat (POST) by Inner Diameter Size of the TaperGuardTM Endotracheal Tube (ETT) ENROLLING_BY_INVITATION

Other Devices by Standard Bariatrics, Inc.

K231603Standard Staple-Line Reinforcement (SSLR23)

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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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