510(k) Report

FDA applicant

Anx Robotica Corp

Plano, TX10 decisions2019–20250 recalls

FDA records 10 decisions for Anx Robotica Corp (Plano, TX) from 2019 to 2025: 9 510(k) clearances and 1 De Novo grant. Most are in product codes QKZ (Magnetically Maneuvered Capsule Endoscopy System) and FFX (System, Gastrointestinal Motility (Electrical)). Its devices cite 9 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Anx Robotica Corporation”, “Anx Robotica, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Anx Robotica Corp’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12020: 22021: 12022: 12023: 22024: 22025: 1
2019high 2 (2020) · low 1 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Anx Robotica Corp by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Anx Robotica Corp’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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