EXQClass II
Cystometer, Electrical Recording
21 CFR 876.1620 / Gastroenterology, Urology
EXQ is the FDA product code for Cystometer, Electrical Recording, a class II device type, regulated under 21 CFR 876.1620. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- EXQ
- Device name
- Cystometer, Electrical Recording
- Regulation
- 21 CFR 876.1620
- 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
- 8
- Ingested recalls
- 1
Clearances, product code EXQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1981 | 1 |
| 1988 | 1 |
| 1993 | 3 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code EXQ| Applicant | Clearances |
|---|---|
| Bright Uro, Inc. | 2 |
| Dacomed Corp. | 1 |
| F.M. Wiest USA, Inc. | 1 |
| Abbott Medical | 1 |
| Life-Tech Instruments, Inc. | 1 |
| Life-Tech Intl., Inc. | 1 |
| Murray, Salk, Inc. | 1 |
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.