FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JIMMY JOHN III
K Number: K842083
·
Decision Oct 24, 1984
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
39
Applicant Total
8
Review Days
154
Basic Information
- Device Name
- JIMMY JOHN III
- K Number
- K842083
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5220
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- COLON THERAPEUTICS
- Date Received
- May 23, 1984
- Decision Date
- October 24, 1984
- 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 |
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Other Clearances by COLON THERAPEUTICS
| K Number | Device Name | ||
|---|---|---|---|
| K973256 | JIMMY JOHN III RECTAL NOZZLE | Sep 29, 1997 | Substantially Equivalent |
| K972455 | JIMMY JOHN III RECTAL NOZZEL, MODEL CIT | Sep 9, 1997 | Substantially Equivalent |
| K881720 | JIMMY JOHN III | Jul 20, 1988 | Substantially Equivalent |
| K873948 | MODIFIED RECTAL NOZZLE | Oct 14, 1987 | Substantially Equivalent |
| K870376 | JIMMY JOHN III, COLONIC IRRIGATION SYSTEM | Mar 17, 1987 | Substantially Equivalent |
| K870127 | MODIFIED JIMMY JOHN III | Mar 17, 1987 | Substantially Equivalent |
| K860943 | JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION) | May 15, 1986 | Substantially Equivalent |