Identity
- Trade Name
- NaviCam Tether FDA UDI
- Generic Name
- Video capsule endoscopy system capsule FDA UDI
- Device Name
- Tether Accessory. The NaviCam Capsule and NaviCam Tether are disposable sterile products, which serve as an accessory to the NaviCam System to allow for examination of the esophagus prior to releasing the NaviCam Capsule into the stomach. The NaviCam Tether is comprised of a tube which on one end is attached to a capsule cradle and on the other end is attached to a syringe connector. The capsule cradle holds the capsule in place while examining the esophagus. The tube is used to control the downward speed of the capsule in the esophagus. The syringe connector serves for releasing the capsule by attaching to it a standard syringe filled with air. 2 NaviCam Stomach Capsule and NaviCam Tether. After the examination of the esophagus is accomplished, the syringe piston is pushed to release the capsule for examining the stomach with the NaviCam System. FDA UDI
- Model / Reference
- CEE-1 FDA UDI
- Description
- Tether Accessory. The NaviCam Capsule and NaviCam Tether are disposable sterile products, which serve as an accessory to the NaviCam System to allow for examination of the esophagus prior to releasing the NaviCam Capsule into the stomach. The NaviCam Tether is comprised of a tube which on one end is attached to a capsule cradle and on the other end is attached to a syringe connector. The capsule cradle holds the capsule in place while examining the esophagus. The tube is used to control the downward speed of the capsule in the esophagus. The syringe connector serves for releasing the capsule by attaching to it a standard syringe filled with air. 2 NaviCam Stomach Capsule and NaviCam Tether. After the examination of the esophagus is accomplished, the syringe piston is pushed to release the capsule for examining the stomach with the NaviCam System. FDA UDI
Identifiers
- Catalog Number
- ES-US-3002 FDA UDI
- Primary DI / UDI-DI
- 00850015518287 FDA UDI
- 510(k) Number
- K221608 FDA UDI
- FDA Product Code
- QKZ FDA UDI
- GMDN Term
- Video capsule endoscopy system capsule FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Video capsule endoscopy system capsule
NaviCam Tether by Anx Robotica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Video capsule endoscopy system capsule.
- MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II
- PillCam — Given Imaging , Ltd. · Class II
- Pillcam — Given Imaging , Ltd. · Class II
- MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II
- MiroCam Capsule Endoscope System — IntroMedic Co., LTD. · Class II
- Pillcam — Given Imaging , Ltd. · Class II
- PillCam — Given Imaging , Ltd. · Class II
- PillCam — Given Imaging , Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Anx Robotica Corp.
Sources (1)
- FDA UDI faef845e-bdbf-43a2-b9f9-20bfbf8661a2 36 fields · synced May 30, 2026