510(k) Report

FDA applicant

Ndo Surgical, Inc.

Mansfield, MA6 decisions2003–20081 recall

FDA records 6 decisions for Ndo Surgical, Inc. (Mansfield, MA) from 2003 to 2008: 6 510(k) clearances. Most are in product codes ODE (Endoscopic Suture/Plication System…) and OCW (Endoscopic Tissue Approximation Device). Its devices cite 13 predicates, 9 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Ndo Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 22008: 1
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Ndo Surgical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ndo Surgical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)5decisions
  • OCWEndoscopic Tissue Approximation Device1decision

Whose devices does it build on?

Its devices cite 13 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K023234Endoscopic Plication SystemNdo Surgical, Inc. · 20036cite it
  • K071553Endoscopic Plication System; Eps; PlicatorNdo Surgical, Inc. · 20074cite it
  • K032820Modification to Endoscopic Plication SystemNdo Surgical, Inc. · 20032cite it
  • K031262Endoscopic Plication System, Model 160-00760Ndo Surgical, Inc. · 20031cites it
  • K072125Endoscopic Plication System, Eps, Eplicator, Plicator InstrumentNdo Surgical, Inc. · 20071cites it
  • K073671Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture CartridgeNdo Surgical, Inc. · 20081cites it

What has FDA decided for it lately?

  • K073671Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture CartridgeNdo Surgical, Inc. · 2008
  • K072125Endoscopic Plication System, Eps, Eplicator, Plicator InstrumentNdo Surgical, Inc. · 2007
  • K071553Endoscopic Plication System; Eps; PlicatorNdo Surgical, Inc. · 2007
  • K032820Modification to Endoscopic Plication SystemNdo Surgical, Inc. · 20031 recall
  • K031262Endoscopic Plication System, Model 160-00760Ndo Surgical, Inc. · 2003
  • K023234Endoscopic Plication SystemNdo Surgical, Inc. · 2003

All 6 as Ndo Surgical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K032820Plicator EPS Plication System Catalog Number: 160-01128RJan 26, 2007