Apollo ESG NXT System, Apollo REVISE NXT System
FDA 510(k) K232544 · Apollo Endosurgery, Inc.
510(k) numberK232544
Submission
- Device name
- Apollo ESG NXT System, Apollo REVISE NXT System
- Applicant
- Apollo Endosurgery, Inc.
Austin, TX, US - Received
- August 22, 2023
- Decision date
- September 18, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QTD – Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5983
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss.
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|---|---|---|
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| K201808 | X-Tack Endoscopic HeliX Tacking SystemPKL · Traditional | 12/15/2020SE |
| K191439 | OverStitch 2-0 Polypropylene SutureOCW · Traditional | 08/29/2019SE |
| K181141 | OverStitch Endoscopic Suturing System and AccessoriesOCW · Special | 06/27/2018SE |
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| K122270 | Overtube Endoscopic Access SystemFED · Traditional | 09/28/2012SE |
| K103155 | Sumo Access and Tissue Resection SystemODC · Traditional | 10/28/2011SE |
| K082102 | Gastric Port, Models: GAP-0016-00, GAP-0018-00, GAP-0020-00FED · Traditional | 06/14/2010SESU |
| K090583 | Endoscopic Monopolar Scissors, Models EMS-235, EMS-165KGE · Traditional | 06/26/2009SE |
Questions and answers
When was Apollo ESG NXT System, Apollo REVISE NXT System cleared by the FDA?
Apollo ESG NXT System, Apollo REVISE NXT System (K232544) received a 510(k) decision of Substantially Equivalent on September 18, 2023, 27 days after the submission was received.
What is the product code of K232544?
The FDA product code is QTD – Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss, a Class II (moderate risk) device regulated under 21 CFR 876.5983.