ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760— 510(k) K031262

Name: FDA 510(k) clearance K031262
Creator: U.S. Food and Drug Administration
Published: 2003-05-23

Substantially Equivalent

Ndo Surgical, Inc.

FDA 510(k) clearance K031262 for ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760, Substantially Equivalent on 2003-05-23. Applicant: Ndo Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Ndo Surgical, Inc.
Product code: Code ODE
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2003-04-21
Decision date: 2003-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODE

view all

K233240 — GERDX-System2024-06-21
K240879 — EsophyX Z+ Device with SerosaFuse Fasteners and Accessories2024-04-26
K172811 — EsophyX Z, EsophyX2 HD2017-10-19
K171307 — EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories2017-06-22
K160960 — EsophyX® Z Device with SerosaFuse Fasteners and Accessories2016-05-01

More clearances from Ndo Surgical, Inc.

view all

K073671 — PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE2008-03-26
K072125 — ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT2007-10-18
K071553 — ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR2007-09-18
K032820 — MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM2003-10-23
K023234 — ENDOSCOPIC PLICATION SYSTEM2003-04-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.