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Endoscopic Plication System, Model 160-00760

by Ndo Surgical, Inc.

510(k) K031262

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK031262 Date23 May 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ODE
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Endoscopic Plication System is a medical device used to create full-thickness, serosa-to-serosa plications in the stomach near the gastroesophageal junction for the treatment of GERD. The system consists of an endoscopic plication instrument, a retractor, and an implant cartridge. It is designed to be used endoscopically to deliver implants and create the plications.

The device is supplied as a single-use system and is regulated under FDA 510(k) clearance with product code ODE. It is intended for use in gastroenterology and urology procedures. The device has been determined to be substantially equivalent to predicate device K023234, indicating comparable safety and effectiveness for its intended use.

Other devices from Ndo Surgical, Inc.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Endoscopic Plication System used for?

    The Endoscopic Plication System is used to create full-thickness, serosa-to-serosa plications in the stomach near the gastroesophageal junction for the treatment of GERD. It is designed for endoscopic use in gastroenterology and urology procedures.

  • How is the Endoscopic Plication System supplied?

    The system is supplied as a single-use system and consists of an endoscopic plication instrument, a retractor, and an implant cartridge. It is regulated under FDA 510(k) clearance with product code ODE.

  • Is the Endoscopic Plication System reusable or single-use?

    The Endoscopic Plication System is supplied as a single-use system and should not be reused for patient safety reasons. Each component is designed for one procedure only.

  • What is the regulatory status of the Endoscopic Plication System?

    The device has FDA 510(k) clearance with product code ODE and has been determined to be substantially equivalent to predicate device K023234. It is intended for use in gastroenterology and urology procedures.