FDA.reportPublic FDA data

MotiliCap GI Monitoring System Mobile Phone/App

Primary DI
00810164590817
Brand
MotiliCap GI Monitoring System Mobile Phone/App
Company
ANX ROBOTICA CORP
Model
MO-US-8010
Catalog number
MO-US-8010
Device description
The MotiliCap Phone is used with the MotiliCap GI Monitoring System for the patient to record specified events during the procedure that will be incorporated into the final data analysis through MotiliScan.
Published
2026-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NYVGastrointestinal Motility System, Capsule

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYVGastrointestinal Motility System, CapsuleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250493000MotiliCap GI Monitoring SystemAnx Robotica Corporation2025-05-21NYV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810164590817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810164590817008101645908178101645908170810164590817

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal telemetric monitoring systemAn assembly of devices designed to continuously measure and transmit signals for one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding) from a patient to a receiving location for viewing. It consists of a battery-powered capsule swallowed by the patient, and a patient-worn or clinician-held unit designed to wirelessly receive data from the capsule to either transmit it (i.e., a transceiver) to a computing device or to display it (e.g., a receiver); various solutions/containers may also be included. It is intended to help diagnose gastric pH disorders and/or measure gastrointestinal transit times to evaluate motility disorders.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-777-0020info@anxrobotics.com

Regulatory Flags#

DUNS number
024972857
Device count
1
Lot or batch
true
Manufacturing 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
00850015518287NaviCam TetherCEE-1ES-US-30022023-01-05
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
00810164590633MotiliCap GI Monitoring System Data RecorderANX ROBOTICA CORPNYV2026-02-09
00810164590640MotiliCap GI Monitoring System Software (MotiliScan)ANX ROBOTICA CORPNYV2026-02-09
00810164590657MotiliCap GI Monitoring System CapsuleANX ROBOTICA CORPNYV2026-02-09
09359921000073Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000196Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000004Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000141Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000172Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000202Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
09359921000318Atmo BiosciencesATMO BIOSCIENCES LIMITEDNYV2025-08-05
04260167482682SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167482705SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167482712SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167482873SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167482880SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167482897SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167482903SmartPillGiven Imaging, Inc.NYV2017-02-13
04260167483573SmartPillGiven Imaging, Inc.NYV2017-02-13
07290101367390SmartPillGiven Imaging, Inc.NYV2017-02-13