APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
FDA 510(k) clearance DEN210045 · decided 2022-07-12
Clearance details
- K-number
- DEN210045
- Device name
- APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
- Applicant
- Apollo Endosurgery, Inc.
- Decision
- Unknown
- Date received
- 2021-09-30
- Decision date
- 2022-07-12
- Days to decision
- 285 days
- Clearance type
- Direct
- Product code
- QTD
- Device class
- 2
- Regulation number
- 876.5983
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Apollo Endosurgery
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Apollo ESG NXT System, Apollo REVISE NXT System (K232544) | Apollo Endosurgery, Inc. | 2023-09-18 |
Recalls involving this device
No recalls on record reference this clearance.