Transenterix, Inc.
United StatesFDA applicant, unverified
- Devices
- 15
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Transenterix, Inc. makes
Transenterix, Inc. manufactures single-port laparoscopic surgical systems, including the Senhance Surgical System with integrated ultrasonic technology for tissue dissection and coagulation. The company also produces a range of reusable SPIDER surgical instruments, such as blunt dissectors, band passers, graspers, hooks, and single-port device accessories designed for minimally invasive procedures.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. Products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Search and filter all 15 devicesFDA recalls
FDA recall records list 4 recalls initiated by Transenterix, Inc., the earliest on 2010-06-22 and the most recent on 2012-07-02. By recorded status: 4 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 2 Jul 2012 Z-2137-2012 Class II Terminated Some clip applier units may be inadequate to achieve clip closure.
2011
- 25 Feb 2011 Z-1909-2011 Unclassified (pre-2012) Terminated Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.
- 25 Feb 2011 Z-1910-2011 Unclassified (pre-2012) Terminated Plastic shards may break off and fall into the abdominal space which may require retrieval during surgery.
2010
- 22 Jun 2010 Z-2465-2010 Unclassified (pre-2012) Terminated The hook end effecter from a monopolar device may become dislodged and fall into the patient when in use during laproscopic surgery. Retrieval from the patient may involve extended anesthesia time.
Frequently asked questions
How many devices does Transenterix, Inc. have in the registry?
The registry currently lists 15 devices for Transenterix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Transenterix, Inc.'s devices?
Among its 15 most recently registered devices, Transenterix, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Transenterix, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Transenterix, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Transenterix, Inc.?
FDA recall records list 4 recalls initiated by Transenterix, Inc., the most recent initiated on 2 Jul 2012. 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 Transenterix, Inc. in the registry?
The most recently registered devices listed for Transenterix, Inc. include Senhance Surgical System, SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER, Senhance Ultrasonic System and SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015.