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FDA 510(k)

LITE WAND II

K-Number: K080962 · 2008-06-25

ApplicantThompson Surgical Instruments, Inc.
Decision Date2008-06-25
Product CodeFST
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LITE WAND II is the device name listed in this FDA 510(k) record. The listed applicant is Thompson Surgical Instruments, Inc.. It received FDA 510(k) clearance on 2008-06-25 under 510(k) number K080962. The device is classified under product code FST. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITE WAND II?

LITE WAND II is a medical device that received FDA 510(k) clearance on 2008-06-25. The listed applicant is Thompson Surgical Instruments, Inc.. The 510(k) number is K080962.

When did LITE WAND II receive FDA 510(k) clearance?

LITE WAND II received FDA 510(k) clearance on 2008-06-25, under 510(k) number K080962.

Who is the listed applicant for LITE WAND II?

The FDA 510(k) record lists Thompson Surgical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LITE WAND II?

The FDA product code for LITE WAND II is FST.

Other records listing Thompson Surgical Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)

Related Devices (Code: FST)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200874TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal EndInnovasis, Inc.K122637LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999Stryker SpineK113697EIGR SURGICAL ILLUMINATION SYSTEMInvuity, Inc.K113330CABLECAPSensormedK102266ISOLED AC-POWERED LED HEADLIGHT SYSTEMIsolux, LLCK101496CABLECAP MODEL: WLF, STZ, ACMSensormed

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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