510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K142113Substantially Equivalent

Esophyx2 Hd

Endogastric Solutions, Inc., Gardnerville NV / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142113 is the FDA 510(k) clearance record for ESOPHYX2 HD, a class II device, cleared for Endogastric Solutions, Inc. on under FDA product code ODE (Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)). FDA's definition for product code ODE reads: "To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant". FDA records list 11 510(k) clearances for Endogastric Solutions, Inc., from to . As of , FDA records show no recalls naming K142113.

Clearance record

Decision date
Received
(57 days to decision)
Product code
ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Endogastric Solutions, Inc. 340 Jones Ln., Gardnerville NV
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ODE

Trailing 12 months

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

FDA records show no clearances under product code ODE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ODE, 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