510(k) K232544
K232544 is an FDA 510(k) premarket notification submitted by Apollo Endosurgery, Inc. for the device "Apollo ESG NXT System, Apollo REVISE NXT System". The FDA issued a decision of Substantially Equivalent on September 18, 2023. 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
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2023
- Date Received
- August 22, 2023
- Clearance Type
- Special
- 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.