510(k) K032820

MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM by Ndo Surgical, Inc. — Product Code ODE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 23, 2003
Date Received: September 10, 2003
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.

Other clearances by Ndo Surgical, Inc.

K073671 — PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SU (March 26, 2008)
K072125 — ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT (October 18, 2007)
K071553 — ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR (September 18, 2007)
K031262 — ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 (May 23, 2003)
K023234 — ENDOSCOPIC PLICATION SYSTEM (April 17, 2003)

Other clearances for product code ODE

K233240 — GERDX-System (June 21, 2024)
K240879 — EsophyX Z+ Device with SerosaFuse Fasteners and Accessories (April 26, 2024)
K172811 — EsophyX Z, EsophyX2 HD (October 19, 2017)
K171307 — EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device w (June 22, 2017)
K160960 — EsophyX® Z Device with SerosaFuse Fasteners and Accessories (May 1, 2016)
K151001 — MUSE System (June 5, 2015)
K143645 — EsophyX® Z Fastener Delivery Device (March 4, 2015)
K143634 — MUSE System (January 20, 2015)
K142113 — ESOPHYX2 HD (September 30, 2014)
K132151 — SRS ENDOSCOPIC STAPLING SYSTEM (March 19, 2014)