SNAP 2.0 Endoscopic Delivery Device SFM-25A-1

GUDID 00860012315550

The SNAP 2.0 Endoscopic Delivery System comes pre-assembled with a Flexagon SFM magnet loaded inside it, with the SFM packed within an Introducer that protects the magnet during transportation and facilitates the introduction of the Flexagon into the endoscope’s working channel. Upon device setup, the SNAP 2.0’s handle section is mounted onto the side of the endoscope with an integrated clip/clamp. The catheter shaft consists of a stainless-steel torque coil that provides column strength to facilitate the Flexagon’s advancement through the gastroscope's 3.7mm minimum working channel for magnet implant placement during gastrointestinal surgery.

G.I. Windows, Inc.

Gastrointestinal anastomosis coupler, non-bioabsorbable

• Primary Device ID: 00860012315550
• NIH Device Record Key: 2a8a2058-7d91-49af-a1cf-01df7982ca0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SNAP 2.0 Endoscopic Delivery Device
• Version Model Number: 100008
• Catalog Number: SFM-25A-1
• Company DUNS: 077112264
• Company Name: G.I. Windows, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012315550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243482

FDA Product Code

• SAH: Magnetic Compression Anastomosis System

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: 2026-02-04
• Device Publish Date: 2026-01-27

Devices Manufactured by G.I. Windows, Inc.

• 00860012315512 - FlexFire Universal Handpiece: 2026-02-04 The FlexFire Universal delivery tool consists of a handpiece and a distal cartridge. The Handpiece provides the user interface
• 00860012315529 - FlexFire Universal Cartridge - Flexagon( A) Plus OTOLoc: 2026-02-04 The FlexFire Universal delivery tool consists of a handpiece and a distal cartridge. The Cartridge to allow for laparoscopic ac
• 00860012315536 - FlexFire Universal Cartridge - Flexagon (B) Plus OTOLoc: 2026-02-04 The FlexFire Universal delivery tool consists of a handpiece and a distal cartridge. The Cartridge to allow for laparoscopic ac
• 00860012315543 - FlexFire Universal Cartridge OTOLoc Only: 2026-02-04 The FlexFire Universal delivery tool consists of a handpiece and a distal cartridge. The Cartridge to allow for laparoscopic ac
• 00860012315550 - SNAP 2.0 Endoscopic Delivery Device: 2026-02-04 The SNAP 2.0 Endoscopic Delivery System comes pre-assembled with a Flexagon SFM magnet loaded inside it, with the SFM packed within an Introducer that protects the magnet during transportation and facilitates the introduction of the Flexagon into the endoscope’s working channel. Upon device setup, the SNAP 2.0’s handle section is mounted onto the side of the endoscope with an integrated clip/clamp. The catheter shaft consists of a stainless-steel torque coil that provides column strength to facilitate the Flexagon’s advancement through the gastroscope's 3.7mm minimum working channel for magnet implant placement during gastrointestinal surgery.
• 00860012315550 - SNAP 2.0 Endoscopic Delivery Device: 2026-02-04 The SNAP 2.0 Endoscopic Delivery System comes pre-assembled with a Flexagon SFM magnet loaded inside it, with the SFM packed wi
• 00860012315505 - Titanium Grasper: 2024-08-15 The GI Windows Titanium Grasper is a surgical laparoscopic grasper with a non-ferrous distal actuator that is intended to be use