FDA Product Code
FDA Product Code QTD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5983
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | Apollo Endosurgery, Inc. | 2023-09-18 | Special | PDF ↗ |
| DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System | Apollo Endosurgery, Inc. | 2022-07-12 | Direct | — |
Product code QTD · Class II · Gastroenterology, Urology. Data: openFDA.