510(k) Report

FDA applicant

Arkis Biosciences, Inc.

Knoxville, TN1 decision2017–20171 recall

FDA records 1 decision for Arkis Biosciences, Inc. (Knoxville, TN) in 2017: 1 510(k) clearance. All are in product code JXG (Shunt, Central Nervous System And Components). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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, neurology panel, where it files most

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

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2017high 1 (2026) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Arkis Biosciences, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JXGShunt, Central Nervous System And Components1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K170599SureFlo EVD CatheterArkis Biosciences, Inc. · 20171 recall

The one decision as Arkis Biosciences, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K170599Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID…Apr 10, 2026Class II