510(k) Report

FDA applicant

Porges Corp.

Gary, IN22 decisions1988–20021 recall

FDA records 22 decisions for Porges Corp. (Gary, IN) from 1988 to 2002: 22 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and EZL (Catheter, Retention Type, Balloon). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Porges S.A.”.

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 Porges Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Porges Corp. since 2007.

Recalls per year

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Porges Corp.’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 “Porges”

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