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510(k) Data Aggregation
K Number
K211203Device Name
Green OR Reprocessed Aquamantys Bipolar Sealer
Manufacturer
Green OR, LLC.
Date Cleared
2022-04-07
(350 days)
Product Code
NUJ
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Green OR, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Green OR Reprocessed Aquamantys Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with a qualified Pump Generator for delivery of radio-frequency (RF) energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The Green OR Reprocessed Aquamantys 2.3 Bipolar Sealer is intended for, but not limited to orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery.
The Green OR Reprocessed Aquamantys 6.0 Bipolar Sealer is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery.
The Green OR Reprocessed Aquamantys 9.5 XL Bipolar Sealer is intended for, but not limited to open abdominal, orthopaedic, and thoracic surgery.
Device Description
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