FDA applicant

Flexible Stenting Solutions, Inc.

Eatontown, NJ5 decisions2009–20129 recalls

FDA records 5 decisions for Flexible Stenting Solutions, Inc. (Eatontown, NJ) from 2009 to 2012: 5 510(k) clearances. All are in product code FGE (Stents, Drains And Dilators For The Biliary…). 9 recalls are 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 Flexible Stenting Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2009high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

6in 2021

2009high 6 (2021) · low 0 (2009)2026

Class I Class II/III not classified

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

Planning a device like Flexible Stenting Solutions, Inc.’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 “Flexible”

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

Flexible Dimensions, LLC 1

Flexible Stenting Solutions, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Flexible”