FDA applicant

Surgichip, Inc.

Palm Beach Gardens, FL1 decision2004–20040 recalls

FDA records 1 decision for Surgichip, Inc. (Palm Beach Gardens, FL) in 2004: 1 510(k) clearance. All are in product code FZZ (Marker, Skin). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Surgichip, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Surgichip, Inc.’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

Surgichip, Inc.

Which product codes does it file in?

What has FDA decided for it lately?