Starion Instruments
Country not established
- Devices
- 13
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Starion Instruments makes
Starion Instruments manufactures electrosurgical devices for tissue cutting, coagulation, and dissection, including powered cautery graspers, dissectors, clamps, forceps, shears, and thermal probes. These instruments are designed for surgical procedures requiring precise thermal control, such as ligation, sealing, and dissection of tissue. Battery-powered and AC-powered units are part of the portfolio, alongside footpedal-controlled forceps for hands-free operation.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they are subject to compliance with the FDA’s medical device regulations. No additional registries or international authorisations are referenced.
Catalogue
Search and filter all 13 devicesFDA recalls
FDA recall records list 3 recalls initiated by Starion Instruments, the earliest on 2008-02-06 and the most recent on 2010-03-09. By recorded status: 3 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.
2010
- 9 Mar 2010 Z-2239-2010 Unclassified (pre-2012) Terminated The Starion Instruments Thermal Ligating Shears (STLS) 35C and the Starion Thermal Ligating Shears (STLS) 23C may turn on and remain on without the finger button being depressed. The devices may also work intermittently, incorrectly indicating the device is 'on".
2008
- 26 Jun 2008 Z-1972-2010 Unclassified (pre-2012) Terminated Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use.
- 6 Feb 2008 Z-1969-2010 Unclassified (pre-2012) Terminated Some jaws exhibited lack of ductility and could break if overloaded or used improperly by placing too much tissue in the bottom of the "v" of the jaw.
Frequently asked questions
How many devices does Starion Instruments have in the registry?
The registry currently lists 13 devices for Starion Instruments. Devices recorded under merged duplicate company entries are counted once.
Which registries list Starion Instruments's devices?
Among its 13 most recently registered devices, Starion Instruments has devices listed in FDA 510(k) (13 devices).
What risk classes do Starion Instruments's devices fall under?
Among its 13 most recently registered devices, the classes recorded for Starion Instruments's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Starion Instruments?
FDA recall records list 3 recalls initiated by Starion Instruments, the most recent initiated on 9 Mar 2010. 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 Starion Instruments in the registry?
The most recently registered devices listed for Starion Instruments include STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR, CAUTERY GRASPER/DISSECTOR, THERMAL CAUTERY PROBE and STARION INSTRUMENTS POWER POINT CAUTERY CLAMP.