FDA applicant

Sri Surgical

Tampa, FL1 decision2009–20090 recalls

FDA records 1 decision for Sri Surgical (Tampa, FL) in 2009: 1 510(k) clearance. All are in product code FYA (Gown, Surgical). 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, general and plastic surgery panel, where it files most

How often FDA has decided Sri Surgical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Sri Surgical by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Sri Surgical

Which product codes does it file in?

What has FDA decided for it lately?