FDA applicant

Stryker GI

Flower Mound, TX1 decision2008–20080 recalls

FDA records 1 decision for Stryker GI (Flower Mound, TX) in 2008: 1 510(k) clearance. All are in product code FDF (Colonoscope And Accessories, Flexible/Rigid). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Stryker GI’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Stryker GI by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Stryker GI’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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Other applicant names beginning “Stryker”

FDA records each applicant name separately; these may or may not be the same firm.

Stryker Corp. 354 Stryker Endoscopy 103 Stryker Instruments 77 Stryker Spine 76 Stryker Leibinger GmbH & Co KG 36 Stryker Neurovascular 36 Stryker Sustainability Solutions 34 Stryker Trauma AG 32 Stryker Orthopaedics 24 Stryker Medical 14 Stryker Instruments, Instruments Div. 6 Stryker Corporate 6

Stryker GI

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Stryker”