Can I read SL Aff1E: 510 (K) Summary As Required by Section 807.92 (C) K111732 on EtoBox?
SL Aff1E: 510 (K) Summary As Required by Section 807.92 (C) K111732 by Yael .Yaser. Arroyo is a document available to read on EtoBox.
What is SL Aff1E: 510 (K) Summary As Required by Section 807.92 (C) K111732 about?
The Aquamantys SBS 5.0 Sheathed Bipolar Sealer is a sterile, single-use electrosurgical device designed for hemostatic sealing and coagulation of soft tissue and bone during various surgical procedures. It operates using radio-frequency energy and saline irrigation, and is intended for use in orthopedic, spine, endoscopic, abdominal, and thoracic surgeries, as well as epidural vein sealing. The device has been determined to be substantially equivalent to previously marketed predicate devices, allowing it to
- Author
- Yael .Yaser. Arroyo
- Language
- EN