510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232544Substantially Equivalent

Apollo ESG NXT System, Apollo REVISE NXT System

Apollo Endosurgery, Inc., Austin TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232544 is the FDA 510(k) clearance record for Apollo ESG NXT System, Apollo REVISE NXT System, a class II device, cleared for Apollo Endosurgery, Inc. on under FDA product code QTD (Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss). FDA's definition for product code QTD reads: "This endoscopic device uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss". FDA records list 14 510(k) clearances for Apollo Endosurgery, Inc., from to . As of , FDA records show no recalls naming K232544.

Clearance record

Decision date
Received
(27 days to decision)
Product code
QTD Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
Regulation
21 CFR 876.5983
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Apollo Endosurgery, Inc. 1120 S. Capital Of Texas Hwy., Suite 300, Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QTD

Trailing 12 months

FDA records hold no clearances under product code QTD in the trailing twelve months.

FDA records show no clearances under product code QTD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QTD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260