510(k) K173355
K173355 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Gastric Sizing Balloon Catheter". The FDA issued a decision of Substantially Equivalent - Kit on Nov 17, 2017. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Cook Incorporated has 174 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent - Kit)
- Decision Date
- Nov 17, 2017
- Date Received
- Oct 25, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
- 510(k)