Ndo Surgical, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Ndo Surgical, Inc. makes
Ndo Surgical, Inc. manufactures endoscopic plication systems and associated suturing instruments, including the Plicator and Plicator GSX series. These devices are designed for internal tissue approximation, such as gastric plication procedures, and include cartridges and instruments for suturing. Modifications to the endoscopic plication system are also part of the portfolio.
The company’s portfolio consists of Class II medical devices, regulated under the FDA’s 510(k) clearance process. These devices are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Plicator Gsx Suturing System, Plicator Gsx, Plicator Instrument, Plicator Gsx Suture Cartridge Ref K073671
Regimes: 510(k) Registry: 510(k)Endoscopic Plication System, Model 160-00760 Ref K031262
Regimes: 510(k) Registry: 510(k)Endoscopic Plication System; Eps; Plicator Ref K071553
Regimes: 510(k) Registry: 510(k)Endoscopic Plication System Ref K023234
Regimes: 510(k) Registry: 510(k)Modification To Endoscopic Plication System Ref K032820
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Ndo Surgical, Inc., initiated on 2007-01-26. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 26 Jan 2007 Z-0685-2007 Unclassified (pre-2012) Terminated Device arm may fail to open after being deployed and require surgical intervention to remove
Frequently asked questions
How many devices does Ndo Surgical, Inc. have in the registry?
The registry currently lists 6 devices for Ndo Surgical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ndo Surgical, Inc.'s devices?
Among its 6 most recently registered devices, Ndo Surgical, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Ndo Surgical, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Ndo Surgical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ndo Surgical, Inc.?
FDA recall records list 1 recall initiated by Ndo Surgical, Inc., the most recent initiated on 26 Jan 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Ndo Surgical, Inc. in the registry?
The most recently registered devices listed for Ndo Surgical, Inc. include ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT, PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE, ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 and ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR.