FDA Product Code
FDA Product Code QAJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5330
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253285 | Elitone for Men | Elidah, Inc. | 2026-01-23 | Traditional | PDF ↗ |
| K223884 | ELITONE Urge Urinary Incontinence Device | Elidah, Inc. | 2023-02-24 | Traditional | PDF ↗ |
| K192357 | INNOVO | Atlantic Therapeutics, Ltd. | 2020-01-16 | Traditional | PDF ↗ |
| K183585 | Elitone Device | Elidah, Inc. | 2019-02-11 | Traditional | PDF ↗ |
| DEN170049 | Innovo | Bio-Medical Research, Ltd. | 2018-11-06 | Direct | — |
Product code QAJ · Class II · Gastroenterology, Urology. Data: openFDA.