510(k) K980868
K980868 is an FDA 510(k) premarket notification submitted by Gentle Colonics, Inc. for the device "GC IRRIGATOR". The FDA issued a decision of Substantially Equivalent on August 6, 1998. The device falls under product code KPL (Colonic Irrigation System), a Class II device regulated under 21 CFR 876.5220. Gentle Colonics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 1998
- Date Received
- March 6, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colonic Irrigation System
- Device Class
- Class II
- Regulation Number
- 876.5220
- Review Panel
- GU
- Submission Type