Barosense Endogastric Tube (Egt), Model F0034

Q: What is the product code of K082589?

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) K082589 · Barosense, Inc.

Substantially Equivalent

510(k) numberK082589

Submission

Device name: Barosense Endogastric Tube (Egt), Model F0034
Applicant: Barosense, Inc.
Redwood City, CA, US
Received: September 8, 2008
Decision date: May 22, 2009
Decision: Substantially Equivalent (SESE)
Type: Traditional 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.

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K260965	CVAC Aspiration SystemFED · Special	Calyxo, Inc.	04/13/2026SE
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K250132	Ureteral Access SheathFED · Traditional	Zhejiang YiGao Medical Technology Co., Ltd.	09/05/2025SE
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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
K120126	Barosense Endogastric Tube and Introducer BougieFED · Special	09/10/2012SE
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

Questions and answers

When was Barosense Endogastric Tube (Egt), Model F0034 cleared by the FDA?

Barosense Endogastric Tube (Egt), Model F0034 (K082589) received a 510(k) decision of Substantially Equivalent on May 22, 2009, 256 days after the submission was received.

What is the product code of K082589?

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