510(k) Report

FDA applicant

Flex Medics Corporation

Minnetonka, MN1 decision1993–19930 recalls

FDA records 1 decision for Flex Medics Corporation (Minnetonka, MN) in 1993: 1 510(k) clearance. All are in product code OCY (Endoscopic Guidewire, Gastroenterology-Urology). 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 Flex Medics Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Flex Medics Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • OCYEndoscopic Guidewire, Gastroenterology-Urology1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K923755Flex Finder GuidewireFlex Medics Corporation · 19931cites it

What has FDA decided for it lately?

  • K923755Flex Finder GuidewireFlex Medics Corporation · 1993

The one decision as Flex Medics Corporation →

Other applicant names beginning “Flex”

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

Flex Eyewear, Inc. 1