Barosense Endogastric Tube and Introducer Bougie

Q: What is the product code of K120126?

The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.

FDA 510(k) K120126 · Barosense, Inc.

Substantially Equivalent

510(k) numberK120126

Submission

Device name: Barosense Endogastric Tube and Introducer Bougie
Applicant: Barosense, Inc.
Redwood City, CA, US
Received: January 17, 2012
Decision date: September 10, 2012
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FED – Endoscopic Access Overtube, Gastroenterology-Urology
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.1500
Specialty: Gastroenterology, Urology

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

Other 510(k)s with product code FED

510(k)	Device	Applicant	Decision
K260410	Single Use Ureteral Access SheathFED · Special	Zhejiang Chuangxiang Medical Technology Co., Ltd.	09/11/2026SE
K261915	Navigator Flex Ureteral Access Sheath SetFED · Traditional	Boston Scientific Corporation	08/04/2026SE
K260965	CVAC Aspiration SystemFED · Special	Calyxo, Inc.	04/13/2026SE
K260521	ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050…FED · Traditional	Zhuhai Pusen Medical Technology Co., Ltd.	04/06/2026SE
K252572	Prodeon Urethral Sheath SystemFED · Traditional	Prodeon Medical, Inc.	10/07/2025SE
K250128	Single Use Suction-Evacuation Ureteral Access SheathFED · Traditional	Anhui Happiness Workshop Medical Instruments…	09/19/2025SE
K250132	Ureteral Access SheathFED · Traditional	Zhejiang YiGao Medical Technology Co., Ltd.	09/05/2025SE
K250695	Single-use Ureteral Access SheathFED · Traditional	Shenzhen HugeMed Medical Technical Development…	07/08/2025SE
K251599	Single-use Ureteral Access SheathFED · Special	Hunan Vathin Medical Instrument Co., Ltd.	07/03/2025SE
K250585	LumenaTM Ureteral Access SheathFED · Traditional	Cathegenix (Xiamen) Co., Ltd.	06/27/2025SE

More from Cathegenix (Xiamen) Co., Ltd.

510(k)	Device	Decision
K120147	Ace Stapler and CartridgeOCW · Special	02/17/2012SE
K110829	Ace Stapler and CartridgeOCW · Special	06/03/2011SE
K082044	Ace Stapler, Model F0031OCW · Traditional	05/11/2010SE
K082589	Barosense Endogastric Tube (Egt), Model F0034FED · Traditional	05/22/2009SE

Questions and answers

When was Barosense Endogastric Tube and Introducer Bougie cleared by the FDA?

Barosense Endogastric Tube and Introducer Bougie (K120126) received a 510(k) decision of Substantially Equivalent on September 10, 2012, 237 days after the submission was received.

What is the product code of K120126?

The FDA product code is FED – Endoscopic Access Overtube, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.