510(k) DEN210045
- Device
- APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
- Applicant
- Apollo Endosurgery, Inc.
- 510(k) number
- DEN210045
- Product code
- QTD
- Decision
- Unknown (DENG)
- Decision date
- 2022-07-12
- Date received
- 2021-09-30
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- David M. Hooper
- Address
- 1120 S Capital Of Texas Hwy. Bldg. 1, Suite 300 Austin TX US 78746 78746
FDA Registration Numbers#
- 9681260
- 1000121056
- 3005099803
- 3007695959
- 3010432890
- 1422634
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QTD#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | Apollo Endosurgery, Inc. | 2023-09-18 |