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ENDOGASTRIC SOLUTIONS, INC.

FDA registration: United States Last updated 30 May 2026

Devices
19
Registries
GUDIDFDA 510(k)
FDA recalls
2

Catalogue19

FDA recalls2

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Endogastric Solutions, Inc. has two recall records initiated between February 4, 2013, and June 6, 2013, both of which are marked as terminated. The first involved the EsophyX2Plus device, citing that it was not validated under actual or simulated use conditions prior to distribution. The second concerned the R2001 and R2002 EsophyX2 devices, noting reports of loss of tissue mold control during operation, including one instance requiring surgical intervention to remove the device.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2013

    • 6 Jun 2013 Z-1982-2013 Class II Terminated Endogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold control when operating the R2001 or R2002 EsophyX2 device. In one case, surgical intervention was necessary to remove the device.
    • 4 Feb 2013 Z-1136-2013 Class II Terminated EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.

What ENDOGASTRIC SOLUTIONS, INC. makes

EndoGastric Solutions, Inc. manufactures single-use endoscopic suturing units and implantable fastener kits for minimally invasive procedures, including the EsophyX Z and EsophyX2 HD systems for gastrointestinal applications, along with associated cartridges and accessories.

These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does EndoGastric Solutions, Inc. manufacture?

EndoGastric Solutions, Inc. specializes in single-use endoscopic suturing units and implantable fastener kits. These devices are designed for minimally invasive surgical procedures, particularly in gastrointestinal applications. Examples include the EsophyX Z and EsophyX2 HD systems, along with associated cartridges and accessories like the SerosaFuse® Implantable Fastener Kit. The company focuses on tools that enable precise tissue approximation and closure during endoscopic surgeries.

Where is EndoGastric Solutions, Inc. based?

EndoGastric Solutions, Inc. is headquartered in the United States. The company’s location in the U.S. aligns with regulatory frameworks like the FDA, which governs the classification and listing of its devices.

Which regulatory registries list EndoGastric Solutions, Inc.’s devices?

EndoGastric Solutions, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries track medical devices that have undergone the necessary regulatory pathways, such as premarket notifications or clearances, to ensure compliance with U.S. medical device regulations. Listing in these databases helps healthcare providers and regulators identify and verify the devices.

How are EndoGastric Solutions, Inc.’s devices classified under FDA regulations?

EndoGastric Solutions, Inc.’s devices fall under Class II classification according to FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls—such as performance standards, post-market surveillance, or labeling requirements—to ensure their safety and effectiveness. Class II devices undergo a 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device.

AI-generated from registry data and not verified by a human reviewer.

Information

FDA registration
United States(from the FDA device records)
Phone
425-307-9269
DUNS number
143602659