Ndo Surgical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ndo Surgical, Inc.” (first 2003, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 84 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ODE | Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) | 5 | 5 |
| OCW | Endoscopic Tissue Approximation Device | 1 | 1 |
Review panels
Most recent Ndo Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073671 | PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE | OCW | 2008-03-26 | 90 |
| K072125 | ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT | ODE | 2007-10-18 | 77 |
| K071553 | ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR | ODE | 2007-09-18 | 104 |
| K032820 | MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM | ODE | 2003-10-23 | 43 |
| K031262 | ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 | ODE | 2003-05-23 | 32 |
| K023234 | ENDOSCOPIC PLICATION SYSTEM | ODE | 2003-04-17 | 202 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2007-01-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Ndo Surgical, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00587392: Endoscopic Full-Thickness Plication for the Treatment of GERD: Long-Term Multicenter Results (Completed, started 2004-12)
- NCT00587522: Study of the NDO Endoscopic Plication System For the Treatment of Symptomatic Gastroesophageal Reflux Disease (Completed, started 2001-08)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ndo Surgical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Ndo Surgical, Inc.” (first 2003, latest 2008), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ndo Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ndo Surgical, Inc. is 84 days.
Which FDA product codes appear under Ndo Surgical, Inc.?
The most frequent FDA product codes under this applicant name are ODE (Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd), 5); OCW (Endoscopic Tissue Approximation Device, 1).
Next steps
- See all 6 Ndo Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ODE, Ndo Surgical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.