FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLONIC & ENEMA NOZZLE
K Number: K071057
·
Decision Oct 5, 2007
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
39
Applicant Total
3
Review Days
172
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- COLONIC & ENEMA NOZZLE
- K Number
- K071057
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5220
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tiller Mind Body, Inc.
- Date Received
- April 16, 2007
- Decision Date
- October 5, 2007
- Product Code
- KPL
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPL | Colonic Irrigation System | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPL), ordered by most recent decision date.
Bio Fluff System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Colonic Plus Regular, Small, and Straight Shape Hydrokit
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AQUA CLEANSE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HC-1 AND HC-1 CLASSIC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
THE WATER LILY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology