510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
ODEClass II

Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

ODE is the FDA product code for Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd), a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant". As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
ODE
Device name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
FDA definition
To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
20
Ingested recalls
4

Clearances, product code ODE

By decision year
20 clearances under product code ODE with a decision year between 2000 and 2024, 2003 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code ODE by decision year
YearClearances
20001
20011
20033
20073
20091
20121
20142
20153
20161
20172
20242

Applicants with the most clearances

Product code ODE
Applicants holding the most 510(k) clearances under product code ODE
ApplicantClearances
Endogastric Solutions, Inc.8
Ndo Surgical, Inc.5
Medigus, Ltd.4
C.R. Bard Inc2
G-Surg GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code