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FDA 510(k)

SPIDER FLEX MONOPOLAR HOOK

K-Number: K102646 · 2010-11-03

ApplicantTransenterix, Inc.
Decision Date2010-11-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPIDER FLEX MONOPOLAR HOOK is the device name listed in this FDA 510(k) record. The listed applicant is Transenterix, Inc.. It received FDA 510(k) clearance on 2010-11-03 under 510(k) number K102646. 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 FLEX MONOPOLAR HOOK?

SPIDER FLEX MONOPOLAR HOOK is a medical device that received FDA 510(k) clearance on 2010-11-03. The listed applicant is Transenterix, Inc.. The 510(k) number is K102646.

When did SPIDER FLEX MONOPOLAR HOOK receive FDA 510(k) clearance?

SPIDER FLEX MONOPOLAR HOOK received FDA 510(k) clearance on 2010-11-03, under 510(k) number K102646.

Who is the listed applicant for SPIDER FLEX MONOPOLAR HOOK?

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 FLEX MONOPOLAR HOOK?

The FDA product code for SPIDER FLEX MONOPOLAR HOOK is GCJ.

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Related Devices (Code: 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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