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FDA 510(k)

CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS

K-Number: K090133 · 2009-02-20

ApplicantCook, Inc.
Decision Date2009-02-20
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2009-02-20 under 510(k) number K090133. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS?

CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS is a medical device that received FDA 510(k) clearance on 2009-02-20. The listed applicant is Cook, Inc.. The 510(k) number is K090133.

When did CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS receive FDA 510(k) clearance?

CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS received FDA 510(k) clearance on 2009-02-20, under 510(k) number K090133.

Who is the listed applicant for CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS?

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

What is the FDA product code for CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS?

The FDA product code for CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS is FGE.

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 Cook, 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.

View all 184 devices →

Related Devices (Code: FGE)

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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