FDA applicant

Innovatec Medical Corp.

Duluth, GA1 decision1994–19940 recalls

FDA records 1 decision for Innovatec Medical Corp. (Duluth, GA) in 1994: 1 510(k) clearance. All are in product code GBT (Catheter, Rectal). 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 Innovatec Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Innovatec Medical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Innovatec Medical Corp.

Which product codes does it file in?

What has FDA decided for it lately?