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FDA 510(k)

SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR

K-Number: K122299 · 2012-10-25

ApplicantTransenterix, Inc.
Decision Date2012-10-25
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR is the device name listed in this FDA 510(k) record. The listed applicant is Transenterix, Inc.. It received FDA 510(k) clearance on 2012-10-25 under 510(k) number K122299. 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 SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR?

SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR is a medical device that received FDA 510(k) clearance on 2012-10-25. The listed applicant is Transenterix, Inc.. The 510(k) number is K122299.

When did SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR receive FDA 510(k) clearance?

SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR received FDA 510(k) clearance on 2012-10-25, under 510(k) number K122299.

Who is the listed applicant for SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR?

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 SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR?

The FDA product code for SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR 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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