ClearanceBrief
Company ยท US

Zeta Surgical, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2023 to 2026. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
HAWNeurological Stereotaxic Instrument4
QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System1
SGEExtracranial Positional System For A Transcranial Magnetic Stimulation System1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 9, 2026K261471Zeta TMS Navigation System
Zeta Surgical, Inc.
QFF
May 1, 2026K253663Zeta Navigation System
Zeta Surgical, Inc.
HAW
Oct 10, 2025K251927Zeta Navigation System (ZNS131-US)
Zeta Surgical, Inc.
SGE
Oct 4, 2024K242351Zeta Cranial Navigation System (ZNS131-US)
Zeta Surgical, Inc.
HAW
Jan 10, 2024K233903Zeta Cranial Navigation System (ZNS131-US)
Zeta Surgical, Inc.
HAW
Sep 8, 2023K230661Zeta Cranial Navigation System
Zeta Surgical
HAW

Latest recalls

DateFirm and productCodeLinked 510(k)
No recalls in this window.
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