JOLClass II
Catheter And Tip, Suction
21 CFR 880.6740 / General Hospital
JOL is the FDA product code for Catheter And Tip, Suction, a class II device type, regulated under 21 CFR 880.6740. As of , FDA records hold 84 510(k) clearances under this code, the most recent dated , and 16 recalls.
Classification record
- Product code
- JOL
- Device name
- Catheter And Tip, Suction
- Regulation
- 21 CFR 880.6740
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 84
- Ingested recalls
- 16
Clearances, product code JOL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 2 |
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 4 |
| 1981 | 3 |
| 1982 | 3 |
| 1983 | 5 |
| 1984 | 4 |
| 1985 | 5 |
| 1986 | 1 |
| 1987 | 8 |
| 1989 | 5 |
| 1990 | 2 |
| 1991 | 2 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 16 |
| 1995 | 6 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 4 |
| 2000 | 1 |
| 2001 | 3 |
| 2005 | 1 |
Applicants with the most clearances
Product code JOL| Applicant | Clearances |
|---|---|
| Orion Life Systems, Inc. | 8 |
| Baxter Healthcare Corporation | 4 |
| Sherwood Medical Co. | 4 |
| Arrow Intl., Inc. | 2 |
| Deknatel, Inc. | 2 |
| Geritrex Corp. | 2 |
| Gesco Intl., Inc. | 2 |
| Hydrox Laboratories, Inc. | 2 |
| Medcare Custom Packaging, Inc. | 2 |
| Primary Care Solutions, Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this code- AD Supply Group Limited
- Addn Solutions GmbH & Co. KG
- Adler Instrument Company
- Alleva Medical Devices
- Allmed Medical Textile Co.,Ltd (Viet Nam)
- Alphatec Spine, Inc.
- Ambler Surgical, LLC
- Amsino Medical (Kunshan) Co., Ltd.
- Amsino Medical (Shanghai) Co., Ltd.
- Amsino Medical Group (HK) Company Limited
- Andersen Caledonia Ltd
- Angiplast Pvt. Ltd.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
