FDA applicant

Advanced Surgical Concepts

Bray, IE12 decisions2007–20231 recall

FDA records 12 decisions for Advanced Surgical Concepts (Bray, IE) from 2007 to 2023: 10 510(k) clearances and 2 De Novo grants. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and OTJ (Laparoscopic Single Port Access Device). Its devices cite 23 predicates, 11 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Advanced Surgical Concepts, Ltd.”.

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 Advanced Surgical Concepts’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2021

2007high 1 (2021) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Advanced Surgical Concepts’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

Advanced Surgical Concepts

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?