Salient Surgical Technologies, Inc.
Portsmouth, NH, US
Salient Surgical Technologies, Inc. appears in FDA device records in Portsmouth, NH. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Salient Surgical Technologies, Inc. in 2011.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K111732 | AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER | GEI | Substantially Equivalent | |
| K111285 | AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING | GEI | Substantially Equivalent | |
| K101057 | AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 | GEI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2892-2011 | Aquamantys 2.3 Bipolar Sealer Model #23-113-1. Product Usage: The Aquamantys Bipolar Sealer is a sterile, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization | Insulating material on the shaft of the device may separate and expose the electrical conductor and result in burning the patient skin | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain