Gastric Sizing Balloon Catheter
FDA 510(k) K173355 · Cook Incorporated
510(k) numberK173355
Submission
- Device name
- Gastric Sizing Balloon Catheter
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- October 25, 2017
- Decision date
- November 17, 2017
- Decision
- Unknown (SESK)
- Type
- Special 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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| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore…KNT · Traditional | C.R. Bard, Inc. | 07/10/2026SE |
| K250389 | XNY Disposable Gastric Calibration TubeKNT · Traditional | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 04/10/2025SE |
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| K242901 | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT…KNT · Traditional | Tools For Surgery, LLC | 01/10/2025SE |
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Questions and answers
When was Gastric Sizing Balloon Catheter cleared by the FDA?
Gastric Sizing Balloon Catheter (K173355) received a 510(k) decision of Unknown on November 17, 2017, 23 days after the submission was received.
What is the product code of K173355?
The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.