FDA applicant

Sri/Surgical Express

Austin, TX4 decisions2002–20080 recalls

FDA records 4 decisions for Sri/Surgical Express (Austin, TX) from 2002 to 2008: 4 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and KKX (Drape, Surgical, Antimicrobial). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sri/Surgical Express, Inc.”.

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 Express’s devices, and how often a recall has named them.

FDA decisions per year

3in 2008

2007high 3 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sri/Surgical Express by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Sri/Surgical Express

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?