FDA applicant

Boston Endoscopic Engineering

Foster, RI1 decision2010–20105 recalls

FDA records 1 decision for Boston Endoscopic Engineering (Foster, RI) in 2010: 1 510(k) clearance. All are in product code FCG (Biopsy Needle). Its devices cite 2 predicates, 0 of them its own earlier devices. 5 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 Boston Endoscopic Engineering’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

5in 2017

2010high 5 (2017) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Boston Endoscopic Engineering by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Boston Endoscopic Engineering’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 “Boston”

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

Boston Scientific Corp 809 Boston Scientific Scimed, Inc. 40 Boston Medical Products, Inc. 33 Boston Scientific, Target 19 Boston Surgical Products, Inc. 17 Boston Biomedica, Inc. 12 Boston Scientific Neuromodulation 11 Boston Pacific Medical, Inc. 11 Boston Medical Corp. 8 Boston Aesthetics, Inc. 6 The Boston Medical Group 5 Boston Scientific/Medi-Tech 5

Boston Endoscopic Engineering

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?

Other applicant names beginning “Boston”