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FDA 510(k)

INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS

K-Number: K120012 · 2012-09-11

ApplicantIntegra LifeSciences Corporation
Decision Date2012-09-11
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2012-09-11 under 510(k) number K120012. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS?

INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2012-09-11. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K120012.

When did INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS receive FDA 510(k) clearance?

INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS received FDA 510(k) clearance on 2012-09-11, under 510(k) number K120012.

Who is the listed applicant for INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS?

The FDA product code for INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS is GCJ.

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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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