DRCClass II
Trocar
21 CFR 870.1390 / Cardiovascular
DRC is the FDA product code for Trocar, a class II device type, regulated under 21 CFR 870.1390. As of , FDA records hold 51 510(k) clearances under this code, the most recent dated , and 11 recalls.
Classification record
- Product code
- DRC
- Device name
- Trocar
- Regulation
- 21 CFR 870.1390
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 51
- Ingested recalls
- 11
Clearances, product code DRC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 2 |
| 1981 | 1 |
| 1984 | 1 |
| 1986 | 3 |
| 1987 | 3 |
| 1989 | 4 |
| 1990 | 1 |
| 1991 | 3 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 2 |
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 3 |
| 2001 | 2 |
| 2002 | 3 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2017 | 2 |
| 2018 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2024 | 2 |
Applicants with the most clearances
Product code DRC| Applicant | Clearances |
|---|---|
| Pressure Products Medical Device Manufacturing LLC | 7 |
| Medical Device Technologies, Inc. | 3 |
| North American Instrument Corp. | 3 |
| Advance Medical Designs Inc | 2 |
| E-Z-EM, Inc | 2 |
| Great Batch Medical | 2 |
| Heartport, Inc. | 2 |
| Medcanica, Inc. | 2 |
| Medsurg Industries, Inc. | 2 |
| Merit Medical Systems, Inc. | 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.
