EndoFix Tissue Fixation Device

GUDID 00860014822704

EndoFix Tissue Fixation Device-Enables the approximation of soft tissue in the gastrointestinal (GI) tract using a suture-based implant delivered through an 18 gaugeechogenic needle.

Endofix Medical Technologies, Inc.

Gastrointestinal endoscopic clip, short-term

• Primary Device ID: 00860014822704
• NIH Device Record Key: a7523d00-df0c-480f-911e-ee1dc3ed1e67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoFix Tissue Fixation Device
• Version Model Number: D6000000
• Company DUNS: 145126274
• Company Name: Endofix Medical Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860014822704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251229

FDA Product Code

• FGE: Stents, Drains And Dilators For The Biliary Ducts

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-10
• Device Publish Date: 2026-02-02

Devices Manufactured by Endofix Medical Technologies, Inc.

• 00860014822704 - EndoFix Tissue Fixation Device: 2026-02-10EndoFix Tissue Fixation Device-Enables the approximation of soft tissue in the gastrointestinal (GI) tract using a suture-based implant delivered through an 18 gaugeechogenic needle.
• 00860014822704 - EndoFix Tissue Fixation Device: 2026-02-10 EndoFix Tissue Fixation Device-Enables the approximation of soft tissue in the gastrointestinal (GI) tract using a suture-based
• 00860014822711 - Secure Suture Locking Device: 2026-02-10 Secure Suture Locking Device – Secures the implant assembly with an implant grade suture lock and cuts the suture once approx