510(k) DEN210045
DEN210045 is an FDA 510(k) premarket notification submitted by Apollo Endosurgery, Inc. for the device "APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System". The FDA issued a decision of De Novo Granted on July 12, 2022. The device falls under product code QTD (Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss), a Class II device regulated under 21 CFR 876.5983. Apollo Endosurgery, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 12, 2022
- Date Received
- September 30, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
- Device Class
- Class II
- Regulation Number
- 876.5983
- Review Panel
- GU
- Submission Type
This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss.