Salient Surgical Technologies
Country not established
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Salient Surgical Technologies makes
Salient Surgical Technologies manufactures the AQUAMANTYS Double Cone Bipolar Sealer, a device designed for tissue sealing and coagulation in surgical procedures. This model (23-310-1) is intended for use in minimally invasive surgeries to reduce bleeding and improve hemostasis during operations.
The company’s portfolio is regulated under FDA Class II devices, with the AQUAMANTYS system authorised via the 510(k) pathway. The device is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Aquamantys Sbs 5.0 Sheated Biopolar Sealer Ref K111732
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Salient Surgical Technologies, initiated on 2011-07-18. By recorded status: 1 terminated. The reasons filed fall into these groups: electrical or power and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 18 Jul 2011 Z-2892-2011 Unclassified (pre-2012) Terminated Insulating material on the shaft of the device may separate and expose the electrical conductor and result in burning the patient skin
Full distribution text
- 18 Jul 2011 Z-2892-2011 Unclassified (pre-2012) Terminated Insulating material on the shaft of the device may separate and expose the electrical conductor and result in burning the patient skin
Frequently asked questions
How many devices does Salient Surgical Technologies have in the registry?
The registry currently lists 3 devices for Salient Surgical Technologies. Devices recorded under merged duplicate company entries are counted once.
Which registries list Salient Surgical Technologies's devices?
Among its 3 most recently registered devices, Salient Surgical Technologies has devices listed in FDA 510(k) (3 devices).
What risk classes do Salient Surgical Technologies's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Salient Surgical Technologies's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Salient Surgical Technologies?
FDA recall records list 1 recall initiated by Salient Surgical Technologies, the most recent initiated on 18 Jul 2011. 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 Salient Surgical Technologies in the registry?
The most recently registered devices listed for Salient Surgical Technologies include AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING, AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER and AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1.