GCXClass II
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
21 CFR 880.6740 / General Hospital
GCX is the FDA product code for Apparatus, Suction, Operating-Room, Wall Vacuum Powered, a class II device type, regulated under 21 CFR 880.6740. As of , FDA records hold 87 510(k) clearances under this code, the most recent dated , and 38 recalls.
Classification record
- Product code
- GCX
- Device name
- Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- 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
- 87
- Ingested recalls
- 38
Clearances, product code GCX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 6 |
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 3 |
| 1981 | 4 |
| 1982 | 10 |
| 1983 | 3 |
| 1984 | 1 |
| 1985 | 4 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 4 |
| 1989 | 9 |
| 1990 | 10 |
| 1991 | 5 |
| 1992 | 3 |
| 1993 | 4 |
| 1994 | 1 |
| 1995 | 4 |
| 1996 | 7 |
| 1997 | 2 |
| 1999 | 1 |
| 2004 | 1 |
Applicants with the most clearances
Product code GCX| Applicant | Clearances |
|---|---|
| Westmark, Sterile Packing Systems, Inc. (Sps) | 6 |
| Deknatel, Inc. | 4 |
| Sherwood Medical Co. | 3 |
| Sherwood Medical Industries | 3 |
| Sorensen Research | 3 |
| Stryker Corp. | 3 |
| Abbott Medical | 2 |
| Medtronic, Inc. | 2 |
| Arbor Technologies, Inc. | 2 |
| Boehringer Laboratories, LLC | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
