CE Deliver

GUDID 00867770000285

Capsule Endoscopy Deliver device for transendoscopic delivery to the stomach or duodenum

CAPSOVISION, INC.

Video capsule endoscopy system capsule introducer

• Primary Device ID: 00867770000285
• NIH Device Record Key: ddef471c-e494-4e22-9373-f217fb07fba9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CE Deliver
• Version Model Number: DLV
• Company DUNS: 789635740
• Company Name: CAPSOVISION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00867770000278 [Primary]
GS1	00867770000285 [Package]; Contains: 00867770000278; Package: Carton [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252480

FDA Product Code

• NEZ: System, Imaging, Gastrointestinal, Wireless, Capsule

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-16
• Device Publish Date: 2026-01-08

Devices Manufactured by CAPSOVISION, INC.

• 00867770000285 - CE Deliver: 2026-01-16Capsule Endoscopy Deliver device for transendoscopic delivery to the stomach or duodenum
• 00867770000285 - CE Deliver: 2026-01-16 Capsule Endoscopy Deliver device for transendoscopic delivery to the stomach or duodenum
• 00867770000261 - CapsoCam Plus: 2020-12-21 Convenience Kit: Small Bowel Capsule Endoscope and Capsule Retrieval Kit
• 00867770000254 - CapsoRetrieve: 2020-10-06 Capsule Retrieval Kit Pan
• 00867770000223 - CapsoCloud: 2020-03-10 Web-based software for managing the CapsoCam Plus procedures used by health care providers, readers, download centers, and uploa
• 00867770000209 - CapsoCam Plus: 2020-02-25 Small Bowel Capsule Endoscope
• 00867770000230 - CapsoAccess: 2020-02-25 Capsule Data Access System
• 00867770000216 - CapsoView: 2020-02-24 Software
• 00867770000247 - CapsoRetrieve: 2020-02-24 Capsule Retrieval Kit