510(k) K232544
- Device
- Apollo ESG NXT System, Apollo REVISE NXT System
- Applicant
- Apollo Endosurgery, Inc.
- 510(k) number
- K232544
- Product code
- QTD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-18
- Date received
- 2023-08-22
- Regulation
- 876.5983
- Classification name
- Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- James Shene
- Address
- 1120 S. Capital Of Texas Hwy., Suite 300 Austin TX US 78746 78746
FDA Registration Numbers#
- 1000121056
- 3007695959
- 3010432890
- 9681260
- 1422634
- 3005099803
Source Documents#
Other 510(k) Records For Product Code QTD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System | Apollo Endosurgery, Inc. | 2022-07-12 |