Standard Bougie, 38 Fr.
K-Number: K210437 · 2021-06-29
ApplicantStandard Bariatrics
Decision Date2021-06-29
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Standard Bougie, 38 Fr. is a medical device manufactured by Standard Bariatrics. It received FDA 510(k) clearance on 2021-06-29 under approval number K210437. 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.?
Standard Bougie, 38 Fr. is a medical device that received FDA 510(k) clearance on 2021-06-29. It is manufactured by Standard Bariatrics. The 510(k) number is K210437.
When was Standard Bougie, 38 Fr. approved by the FDA?
Standard Bougie, 38 Fr. received FDA 510(k) clearance on 2021-06-29, under approval number K210437.
What company makes Standard Bougie, 38 Fr.?
Standard Bougie, 38 Fr. is manufactured by Standard Bariatrics.
What is the FDA product code for Standard Bougie, 38 Fr.?
The FDA product code for Standard Bougie, 38 Fr. is KNT.
Other Devices by Standard Bariatrics
Related Devices (Code: KNT)
K163092TubeClear Control Box and Clearing StemActuated Medical, Inc.
K162110CORGRIP NG/NI Tube Retention SystemCorpak Medsystems, Inc. A Division of Haylard Health
K160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with StyletSyncro Medical Innovations, Inc.
K152246Aquarius Stoma Measuring DeviceDegania Silicone , Ltd.
K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management KitConsure Medical Pvt , Ltd.
K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)Covidien, LLC
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.