510(k) Report

FDA applicant

Emcision, Ltd.

London, Uk, GB10 decisions2005–20186 recalls

FDA records 10 decisions for Emcision, Ltd. (London, Uk, GB) from 2005 to 2018: 10 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and KNS (Unit, Electrosurgical, Endoscopic (With Or…). Its devices cite 11 predicates, 6 of them its own earlier devices. 6 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2018

2007: 32008: 22009: 12015: 12016: 12018: 1
2007high 3 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2023

2010: 22019: 22023: 1
2007high 2 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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