510(k) K971901
K971901 is an FDA 510(k) premarket notification submitted by Radius Intl., Inc. for the device "RADIUS LOW PROFILE GASTROSTOMY TUBE KIT". The FDA issued a decision of Substantially Equivalent on January 22, 1998. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Radius Intl., Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 1998
- Date Received
- May 23, 1997
- Clearance Type
- Traditional
- 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