510(k) Report

FDA applicant

Del Medical Systems Corp.

Valhalla, NY7 decisions1994–19960 recalls

FDA records 7 decisions for Del Medical Systems Corp. (Valhalla, NY) from 1994 to 1996: 7 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and FET (Endoscopic Video Imaging System/Component…). Its devices cite 3 predicates, 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, gastroenterology and urology panel, where it files most

How often FDA has decided Del Medical Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Del Medical Systems Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Del Medical Systems 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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