510(k) Report

FDA applicant

Surcraft, LLC

Newport News, VA1 decision1996–19960 recalls

FDA records 1 decision for Surcraft, LLC (Newport News, VA) in 1996: 1 510(k) clearance. All are in product code FHN (Ligator, Hemorrhoidal). 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 Surcraft, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surcraft, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Surcraft, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report