510(k) Report

FDA applicant

Intuitap Medical, Inc.

Houston, TX1 decision2024–20240 recalls

FDA records 1 decision for Intuitap Medical, Inc. (Houston, TX) in 2024: 1 De Novo grant. All are in product code QXD (Spinal Imaging System For Neuraxial Procedures). No recall is linked to its devices.

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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Intuitap Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Intuitap Medical, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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