510(k) Report

FDA applicant

Roen Surgical, Inc.

Daejeon, KR1 decision2026–20260 recalls

FDA records 1 decision for Roen Surgical, Inc. (Daejeon, KR) in 2026: 1 510(k) clearance. All are in product code FGB (Ureteroscope 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 Roen Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

Planning a device like Roen Surgical, 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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Which product codes does it file in?

  • FGBUreteroscope And Accessories, Flexible/Rigid1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K253505Zamenix™ PRoen Surgical, Inc. · 2026

The one decision as Roen Surgical, Inc. →