Connex Gastrointestinal Suture Anchor, Model Gias
FDA 510(k) K090133 · Cook, Inc.
510(k) numberK090133
Submission
- Device name
- Connex Gastrointestinal Suture Anchor, Model Gias
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- January 21, 2009
- Decision date
- February 20, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
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Questions and answers
When was Connex Gastrointestinal Suture Anchor, Model Gias cleared by the FDA?
Connex Gastrointestinal Suture Anchor, Model Gias (K090133) received a 510(k) decision of Substantially Equivalent on February 20, 2009, 30 days after the submission was received.
What is the product code of K090133?
The FDA product code is FGE – Stents, Drains And Dilators For The Biliary Ducts, a Class II (moderate risk) device regulated under 21 CFR 876.5010.