FDA applicant

Scion Medical Technologies, LLC

Newtown Square, PA6 decisions2013–20170 recalls

FDA records 6 decisions for Scion Medical Technologies, LLC (Newtown Square, PA) from 2013 to 2017: 6 510(k) clearances. Most are in product codes NEU (Marker, Radiographic, Implantable) and KNW (Instrument, Biopsy). Its devices cite 10 predicates, 4 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 Scion Medical Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2013high 2 (2013) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Scion Medical Technologies, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Scion Medical Technologies, LLC’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 “Scion”

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

Scion International, Inc. 4 Scion Cardio-Vascular, Inc. 4 Scion Cardiovascular, Inc. 1 Scion Valley, Inc. 1 Scion Neurostim, LLC 1

Scion Medical Technologies, LLC

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?

Other applicant names beginning “Scion”