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FDA 510(k)

ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432

K-Number: K073484 · 2008-03-10

Decision Date2008-03-10
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, Inc.. It received FDA 510(k) clearance on 2008-03-10 under 510(k) number K073484. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432?

ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 is a medical device that received FDA 510(k) clearance on 2008-03-10. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K073484.

When did ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 receive FDA 510(k) clearance?

ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 received FDA 510(k) clearance on 2008-03-10, under 510(k) number K073484.

Who is the listed applicant for ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432?

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

What is the FDA product code for ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432?

The FDA product code for ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432 is ODC.

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.

Other records listing Ethicon Endo-Surgery, 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.

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Related Devices (Code: ODC)

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.

Official Source

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

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