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510(k) Data Aggregation
K Number
K240881Device Name
Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL)
Manufacturer
Covidien (Part of Medtronic)
Date Cleared
2024-11-01
(214 days)
Product Code
GAG, GEN
Regulation Number
878.4740Why did this record match?
Applicant Name (Manufacturer) :
Covidien (Part of Medtronic)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.
Device Description
The Signia™ circular adapters are reusable instruments that connect with the assembled Signia™ power handle and Signia™ power shell to make up the Signia™ stapler. The Signia™ circular adapters are composed of motor-mating connectors, sensor gauges and device communication interfaces to provide functionality and communication between compatible reloads and the Signia™ circular adapters are available in two shaft lengths, standard (25 cm) and extra-long (30 cm).
The Signia™ Circular Adapter are for use with the Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled surgical stapler that provides push-button powered operations and firing of compatible reloads. The Signia™ stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. The Signia™ stapler is intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated. Signia™ Stapler can be used for both linear and circular stapling application depending on the software version installed in the Signia™ power handle.
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