510(k) Report

FDA applicant

Boston Scientific EP Technologies

San Jose, CA1 decision2003–20030 recalls

FDA records 1 decision for Boston Scientific EP Technologies (San Jose, CA) in 2003: 1 510(k) clearance. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Boston Scientific EP Technologies’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Boston Scientific EP Technologies since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K023288Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies · 20033cite it

What has FDA decided for it lately?

  • K023288Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies · 2003

The one decision as Boston Scientific EP Technologies →

Other applicant names beginning “Boston”

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

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