510(k) Report

FDA applicant

Axis Surgical Technologies, Inc.

Mountain View, CA1 decision2010–20100 recalls

FDA records 1 decision for Axis Surgical Technologies, Inc. (Mountain View, CA) in 2010: 1 510(k) clearance. All are in product code HRX (Arthroscope). Its devices cite 3 predicates, 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, orthopedic panel, where it files most

How often FDA has decided Axis Surgical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Axis Surgical Technologies, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HRXArthroscope1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 20102cite it

What has FDA decided for it lately?

  • K093717C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010

The one decision as Axis Surgical Technologies, Inc. →

Other applicant names beginning “Axis”

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

Axis-Shield Diagnostics, Ltd. 28Axis-Shield Poc AS 4Axis-Shield, Ltd. 3Axis Biochemicals, Asa 3Axis Orthopaedics 3Axis-Shield Biochemicals, Asa 2Axis Spine Technologies, Ltd. 2Axis-Shield Doc AS 1Axis 1Axis Health Care, LLC 1