510(k) Report

FDA applicant

Sony Electronics, Inc.

North Attleboro, MA8 decisions2009–20200 recalls

FDA records 8 decisions for Sony Electronics, Inc. (North Attleboro, MA) from 2009 to 2020: 8 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and LMC (Camera, Multi Format, Radiological). Its devices cite 15 predicates, 2 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, gastroenterology and urology panel, where it files most

How often FDA has decided Sony Electronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2009: 12012: 22014: 22015: 12016: 12020: 1
2009high 2 (2012) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Sony Electronics, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sony Electronics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Sony”

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