510(k) Report

FDA applicant

Sohniks Endoscopy, Inc.

Eagan, MN2 decisions2003–20040 recalls

FDA records 2 decisions for Sohniks Endoscopy, Inc. (Eagan, MN) from 2003 to 2004: 2 510(k) clearances. Most are in product codes HRX (Arthroscope) and FAJ (Cystoscope And Accessories, Flexible/Rigid). Its devices cite 1 predicate, 1 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, orthopedic panel, where it files most

How often FDA has decided Sohniks Endoscopy, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sohniks Endoscopy, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sohniks Endoscopy, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sohniks Endoscopy, 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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