510(k) Report

FDA applicant

Encoll Corp.

Newark, CA1 decision2004–20040 recalls

FDA records 1 decision for Encoll Corp. (Newark, CA) in 2004: 1 510(k) clearance. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 7 predicates, 0 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

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

FDA decisions per year

No FDA decision for Encoll Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Encoll 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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