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FDA 510(k)

BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE

K-Number: K120126 · 2012-09-10

ApplicantBarosense, Inc.
Decision Date2012-09-10
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE is the device name listed in this FDA 510(k) record. The listed applicant is Barosense, Inc.. It received FDA 510(k) clearance on 2012-09-10 under 510(k) number K120126. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE?

BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE is a medical device that received FDA 510(k) clearance on 2012-09-10. The listed applicant is Barosense, Inc.. The 510(k) number is K120126.

When did BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE receive FDA 510(k) clearance?

BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE received FDA 510(k) clearance on 2012-09-10, under 510(k) number K120126.

Who is the listed applicant for BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE?

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

What is the FDA product code for BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE?

The FDA product code for BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE is FED.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Barosense, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120147ACE STAPLER AND CARTRIDGEK110829ACE STAPLER AND CARTRIDGEK082044ACE STAPLER, MODEL F0031K082589BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034

Related Devices (Code: FED)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific CorporationK260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

Official Source

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