510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Anx Robotica Corp.

Plano, TX, US

ANX ROBOTICA CORP. appears in FDA device records in Plano, TX. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
10
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 10 510(k) clearances for Anx Robotica Corp. between 2019 and 2025. The busiest year on record is 2020, with 2. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Anx Robotica Corp., by decision year
YearClearances
20191
20202
20211
20221
20232
20242
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K250493MotiliCap GI Monitoring SystemNYVSubstantially Equivalent
K241934NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)QKZSubstantially Equivalent
K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherNEZSubstantially Equivalent
K231960NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam TetherQKZSubstantially Equivalent
K230694NaviCam Xpress Stomach System, NaviCam Xpress SystemQKZSubstantially Equivalent
K221608NaviCam 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 TetherQKZSubstantially Equivalent
K203192NaviCam Xpress Stomach SystemQKZSubstantially Equivalent
DEN190037NaviCam Capsule Endoscope System with NaviCam Stomach CapsuleQKZUnknown
K201106IntraMarX 3D Radiopaque MarkerFFXSubstantially Equivalent
K191087IntraMarX Radiopaque MarkersFFXSubstantially Equivalent

Registered establishments

FDA registered establishments for Anx Robotica Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30165442483016544248ANX ROBOTICA CORP.6010 W. Spring Creek Pkwy, Plano, TX 75024 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Anx Robotica Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain