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FDA 510(k)

IMPLICITGUIDE SURGICAL SUTURE SYSTEM

K-Number: K091061 · 2009-11-13

ApplicantImplicitcare, LLC
Decision Date2009-11-13
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMPLICITGUIDE SURGICAL SUTURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implicitcare, LLC. It received FDA 510(k) clearance on 2009-11-13 under 510(k) number K091061. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLICITGUIDE SURGICAL SUTURE SYSTEM?

IMPLICITGUIDE SURGICAL SUTURE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-11-13. The listed applicant is Implicitcare, LLC. The 510(k) number is K091061.

When did IMPLICITGUIDE SURGICAL SUTURE SYSTEM receive FDA 510(k) clearance?

IMPLICITGUIDE SURGICAL SUTURE SYSTEM received FDA 510(k) clearance on 2009-11-13, under 510(k) number K091061.

Who is the listed applicant for IMPLICITGUIDE SURGICAL SUTURE SYSTEM?

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

What is the FDA product code for IMPLICITGUIDE SURGICAL SUTURE SYSTEM?

The FDA product code for IMPLICITGUIDE SURGICAL SUTURE SYSTEM is GAT.

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Related Devices (Code: GAT)

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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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