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FDA 510(k)

SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER

K-Number: K120403 · 2012-04-16

Decision Date2012-04-16
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER is the device name listed in this FDA 510(k) record. The listed applicant is Transenterix, Inc.. It received FDA 510(k) clearance on 2012-04-16 under 510(k) number K120403. 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 SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER?

SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER is a medical device that received FDA 510(k) clearance on 2012-04-16. The listed applicant is Transenterix, Inc.. The 510(k) number is K120403.

When did SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER receive FDA 510(k) clearance?

SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER received FDA 510(k) clearance on 2012-04-16, under 510(k) number K120403.

Who is the listed applicant for SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER?

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

What is the FDA product code for SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER?

The FDA product code for SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER is GCJ.

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 Transenterix, 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: GCJ)

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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