Cook Gastric Sizing Balloon Catheter
FDA 510(k) K030841 · Cook, Inc.
510(k) numberK030841
Submission
- Device name
- Cook Gastric Sizing Balloon Catheter
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- March 17, 2003
- Decision date
- July 11, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Cook Gastric Sizing Balloon Catheter cleared by the FDA?
Cook Gastric Sizing Balloon Catheter (K030841) received a 510(k) decision of Substantially Equivalent on July 11, 2003, 116 days after the submission was received.
What is the product code of K030841?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.