Colon Therapeutics
Port Arthur, TX, US
Colon Therapeutics appears in FDA device records in Port Arthur, TX. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Colon Therapeutics between 1984 and 1997. The busiest year on record is 1987, with 3. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1986 | 1 |
| 1987 | 3 |
| 1988 | 1 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K973256 | JIMMY JOHN III RECTAL NOZZLE | KPL | Substantially Equivalent | |
| K972455 | JIMMY JOHN III RECTAL NOZZEL, MODEL CIT | KPL | Substantially Equivalent | |
| K881720 | JIMMY JOHN III | KPL | Substantially Equivalent | |
| K873948 | MODIFIED RECTAL NOZZLE | KPL | Substantially Equivalent | |
| K870376 | JIMMY JOHN III, COLONIC IRRIGATION SYSTEM | KPL | Substantially Equivalent | |
| K870127 | MODIFIED JIMMY JOHN III | KPL | Substantially Equivalent | |
| K860943 | JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION) | KPL | Substantially Equivalent | |
| K842083 | JIMMY JOHN III | KPL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain