FDA applicant

Laurus Medical Corp.

Irvine, CA4 decisions1994–19972 recalls

FDA records 4 decisions for Laurus Medical Corp. (Irvine, CA) from 1994 to 1997: 4 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and FCG (Biopsy Needle). 2 recalls are 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 Laurus Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Laurus Medical Corp. since 2007.

Recalls per year

2in 2018

2007high 2 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Laurus Medical Corp.’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

Other applicant names beginning “Laurus”

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

Laurus Medical Group 1

Laurus Medical Corp.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Laurus”