KQTClass II
Evacuator, Gastro-Urology
21 CFR 876.4370 / Gastroenterology, Urology
KQT is the FDA product code for Evacuator, Gastro-Urology, a class II device type, regulated under 21 CFR 876.4370. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 12 recalls.
Classification record
- Product code
- KQT
- Device name
- Evacuator, Gastro-Urology
- Regulation
- 21 CFR 876.4370
- 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
- 14
- Ingested recalls
- 12
Clearances, product code KQT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 3 |
| 1981 | 2 |
| 1983 | 1 |
| 1986 | 1 |
| 1988 | 2 |
| 1991 | 1 |
| 1992 | 2 |
| 1996 | 1 |
Applicants with the most clearances
Product code KQT| Applicant | Clearances |
|---|---|
| Northgate Technologies Inc. | 2 |
| The Healthcare Group Laboratories, Inc. | 2 |
| American Hospital Supply | 1 |
| Bel-Can Industries | 1 |
| Davol, Inc. | 1 |
| E.M.S. - Electro Medical Systems SA | 1 |
| J. H. Emerson Co. | 1 |
| Mitron Technologies, Inc. | 1 |
| R. J. Ltd., Ind. | 1 |
| Sage Products LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Allwin Medical Devices Pvt. Ltd.
- Allwin Medical Devices, Inc.
- Aulea Medical, Inc.
- Baxter Healthcare of Puerto Rico LLC
- Boen Healthcare Co., Ltd.
- Boston Scientific Corporation
- C.R. Bard Inc
- Conod Medical Co., Ltd.
- Conod Medical Shuyang Co., Ltd.
- Cook Incorporated
- E.M.S. - Electro Medical Systems SA
- Endonest Medical Systems LLP
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.
