MNDClass II
Ligator, Esophageal
21 CFR 876.4400 / Gastroenterology, Urology
MND is the FDA product code for Ligator, Esophageal, a class II device type, regulated under 21 CFR 876.4400. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 5 recalls.
Classification record
- Product code
- MND
- Device name
- Ligator, Esophageal
- Regulation
- 21 CFR 876.4400
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 15
- Ingested recalls
- 5
Clearances, product code MND
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 1 |
| 1997 | 2 |
| 1999 | 2 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 2 |
| 2005 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2013 | 1 |
Applicants with the most clearances
Product code MND| Applicant | Clearances |
|---|---|
| C.R. Bard Inc | 4 |
| OLYMPUS Corporation of the Americas | 3 |
| Boston Scientific Corporation | 2 |
| Scandimed International | 2 |
| Ethicon Endo-Surgery Inc | 1 |
| Olympus Corp of America | 1 |
| Scandimed. A.S. | 1 |
| Wilson-Cook Medical Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- AD Supply Group Limited
- Alton Shanghai Medical Instruments Co Ltd
- Aomori Olympus Co., Ltd. Hirosaki Site
- AOMORI OLYMPUS CO., Ltd. Kuroishi Site
- Beijing Zksk Technology Co., Ltd.
- Boston Scientific Corporation
- CBR Enterprise Limited
- Changzhou Health MicroPort Medical Device Co.,Ltd.
- ConMed Corporation
- Consolidated Medical Equipment Company
- Finemedix
- G-Flex Europe SRL
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.
