510(k) Report

FDA applicant

Spatz Fgia, Inc.

Ft. Lauderdale1 decision2021–20210 recalls

FDA records 1 decision for Spatz Fgia, Inc. (Ft. Lauderdale) in 2021: 1 original PMA approval. All are in product code LTI (Implant, Intragastric For Morbid Obesity). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Spatz Fgia, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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