ODE · Class II · 21 CFR 876.1500

FDA Product Code ODE: Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)

To Treat The Symptoms Of Chronic Gastroesophageal Reflux Disease (gerd), Either By Approximating Tissue With Sutures Or Plicating Tissue With An Implant.

Leading manufacturers include Endogastric Solutions, Inc., Ndo Surgical, Inc. and Medigus , Ltd..

20
Total
20
Cleared
86d
Avg days
2000
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) Devices (Product Code ODE)

20 devices
1–20 of 20
Cleared Jun 21, 2024
GERDX-System
K233240
G-Surg GmbH
Gastroenterology & Urology · 267d
Cleared Apr 26, 2024
EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
K240879
Endogastric Solutions, Inc.
Gastroenterology & Urology · 28d
Cleared Oct 19, 2017
EsophyX Z, EsophyX2 HD
K172811
Endogastric Solutions, Inc.
Gastroenterology & Urology · 31d
Cleared Jun 22, 2017
EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories
K171307
Endogastric Solutions, Inc.
Gastroenterology & Urology · 50d
Cleared May 01, 2016
EsophyX® Z Device with SerosaFuse Fasteners and Accessories
K160960
Endogastric Solutions, Inc.
Gastroenterology & Urology · 26d
Cleared Jun 05, 2015
MUSE System
K151001
Medigus , Ltd.
Gastroenterology & Urology · 51d
Cleared Mar 04, 2015
EsophyX® Z Fastener Delivery Device
K143645
Endogastric Solutions, Inc.
Gastroenterology & Urology · 72d
Cleared Jan 20, 2015
MUSE System
K143634
Medigus , Ltd.
Gastroenterology & Urology · 29d
Cleared Sep 30, 2014
ESOPHYX2 HD
K142113
Endogastric Solutions, Inc.
Gastroenterology & Urology · 57d
Cleared Mar 19, 2014
SRS ENDOSCOPIC STAPLING SYSTEM
K132151
Medigus , Ltd.
Gastroenterology & Urology · 251d
Cleared May 18, 2012
SRS ENDOSCOPIC STAPLING SYSTEM
K120299
Medigus , Ltd.
Gastroenterology & Urology · 108d
Cleared Nov 06, 2009
ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5
K092400
Endogastric Solutions, Inc.
Gastroenterology & Urology · 92d
Cleared Oct 18, 2007
ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT
K072125
Ndo Surgical, Inc.
Gastroenterology & Urology · 77d
Cleared Sep 18, 2007
ENDOSCOPIC PLICATION SYSTEM
K071553
Ndo Surgical, Inc.
Gastroenterology & Urology · 104d
Cleared Sep 14, 2007
EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES
K071651
Endogastric Solutions, Inc.
Gastroenterology & Urology · 88d
Cleared Oct 23, 2003
MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM
K032820
Ndo Surgical, Inc.
Gastroenterology & Urology · 43d
Cleared May 23, 2003
ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760
K031262
Ndo Surgical, Inc.
Gastroenterology & Urology · 32d
Cleared Apr 17, 2003
ENDOSCOPIC PLICATION SYSTEM
K023234
Ndo Surgical, Inc.
General & Plastic Surgery · 202d
Cleared Jan 05, 2001
BARD ENDOCINCH SUTURING SYSTEM # 000452
K003956
C.R. Bard, Inc.
Gastroenterology & Urology · 15d
Cleared Mar 20, 2000
BARD ENDOSCOPIC SUTURING SYSTEM
K994290
C.R. Bard, Inc.
Gastroenterology & Urology · 90d

About Product Code ODE - Regulatory Context

510(k) Submission Activity

20 total 510(k) submissions under product code ODE since 2000, with 20 receiving FDA clearance (average review time: 86 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.