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FDA 510(k)

INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM

K-Number: K090070 · 2009-04-22

ApplicantInvuity, Inc.
Decision Date2009-04-22
Product CodeFST
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Invuity, Inc.. It received FDA 510(k) clearance on 2009-04-22 under 510(k) number K090070. 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 INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM?

INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM is a medical device that received FDA 510(k) clearance on 2009-04-22. The listed applicant is Invuity, Inc.. The 510(k) number is K090070.

When did INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM receive FDA 510(k) clearance?

INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM received FDA 510(k) clearance on 2009-04-22, under 510(k) number K090070.

Who is the listed applicant for INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM?

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

What is the FDA product code for INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM?

The FDA product code for INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM is FST.

Related Clinical Trials

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.

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Other records listing Invuity, 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.

K191583PhotonBlade with Smoke EvacuationK162053PhotonBladeK113697EIGR SURGICAL ILLUMINATION SYSTEM

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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