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510(k) K071553

ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR by Ndo Surgical, Inc. — Product Code ODE

K071553 is an FDA 510(k) premarket notification submitted by Ndo Surgical, Inc. for the device "ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR". The FDA issued a decision of Substantially Equivalent on September 18, 2007. The device falls under product code ODE (Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)), a Class II device regulated under 21 CFR 876.1500. Ndo Surgical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2007
Date Received
June 6, 2007
Clearance Type
Traditional
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)
  • K032820 — MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM (October 23, 2003)
  • 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)

FDA data resources