Apollo ESG NXT System, Apollo REVISE NXT System
FDA 510(k) clearance K232544 · decided 2023-09-18
Clearance details
- K-number
- K232544
- Device name
- Apollo ESG NXT System, Apollo REVISE NXT System
- Applicant
- Apollo Endosurgery, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-08-22
- Decision date
- 2023-09-18
- Days to decision
- 27 days
- Clearance type
- Special
- 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
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System (DEN210045) | Apollo Endosurgery, Inc. | 2022-07-12 |
Recalls involving this device
No recalls on record reference this clearance.