FDA.reportPublic FDA data

NaviCam Tether

Primary DI
00850015518287
Brand
NaviCam Tether
Company
ANX ROBOTICA CORP
Model
CEE-1
Catalog number
ES-US-3002
Device 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. 2NaviCam 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.
Published
2023-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QKZMagnetically Maneuvered Capsule Endoscopy System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKZMagnetically Maneuvered Capsule Endoscopy SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221608000NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam TetherAnx Robotica Corp2022-11-22QKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850015518284PackageGS110In Commercial Distribution
00850015518287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001551828410850015518284
00850015518287008500155182878500155182870850015518287

GMDN Terms#

Term, Definition table
TermDefinition
Video capsule endoscopy system capsuleAn electrically-powered, non-digestible capsule containing a video camera designed to pass through the gastrointestinal (GI) tract of a patient after being swallowed or endoscopically introduced, for the internal visualization and examination of the GI tract. It is intended to acquire video images of GI tract sections (e.g., oesophagus, small bowel and colon) and wirelessly transmit the images to a dedicated control unit/monitor (not included) via an external sensor array for examination and data recording. The capsule can be freely mobile or externally controlled by another device (not included); the capsule is excreted from the gut. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-480-2911tim.thomas@anxrobotics.com

Regulatory Flags#

DUNS number
024972857
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810164590114NaviCam Data RecorderSB-US-2003SB-US-20032026-02-16
00810164590145NaviCam LocatorSB-US-2006SB-US-20062026-02-16
00810164590169NaviCam ESView SoftwareESView 2.XSB-US-20062026-02-16
00810164590275NaviCam ProScan AI SoftwareSB-US-2025SB-US-2-252026-02-16
00810164590794NaviCam ESView 3.XESView 3.XSB-US-20262026-02-16
00810164590008NaviCam SB CapsuleCP-US-7001CP-US-70012026-02-09
00810164590039NaviCam SB Capsule/TetherES-US-3001ES-US-30012026-02-09
00810164590633MotiliCap GI Monitoring System Data RecorderMO-US-8001MO-US-80012026-02-09
00810164590640MotiliCap GI Monitoring System Software (MotiliScan)MO-US-8005MO-US-80052026-02-09
00810164590657MotiliCap GI Monitoring System CapsuleCP-US-7010CP-US-70102026-02-09
00810164590718NaviCam XS CapsuleCP-US-7009CP-US-70092026-02-09
00810164590732NaviCam XS Capsule/TetherES-US-3009ES-US-30092026-02-09
00810164590817MotiliCap GI Monitoring System Mobile Phone/AppMO-US-8010MO-US-80102026-02-09
00850015518294NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach SystemController/ NaviEC-2000MC-US-10022023-01-05
00850015518072NaviCam Stomach SystemLocator AKS-1SB-US-20062020-12-08
00850015518188NaviCam Capsule Endoscope SystemRecorder/AKR-1MC-US-10062020-12-08
00850015518195NaviCam Capsule Endoscope SystemStomach Capsule/AKEM-11SWCP-US-70062020-12-08
00850015518201NaviCam Capsule Endoscope SystemController/NaviEC-1000MC-US-10012020-12-08
00850015518003IntraMarX Radiopaque MarkersAGIROMC1-1(R)AGIROMC1-1(R)2020-01-27
00850015518010IntraMarX Radiopaque MarkersAGIROMC1-1(DD)AGIROMC1-1(DD)2020-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850015518294NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach SystemANX ROBOTICA CORPQKZ2023-01-05
00850015518072NaviCam Stomach SystemANX ROBOTICA CORPQKZ2020-12-08
00850015518188NaviCam Capsule Endoscope SystemANX ROBOTICA CORPQKZ2020-12-08
00850015518195NaviCam Capsule Endoscope SystemANX ROBOTICA CORPQKZ2020-12-08
00850015518201NaviCam Capsule Endoscope SystemANX ROBOTICA CORPQKZ2020-12-08