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510(k) Data Aggregation
K Number
K221206Device Name
Compass Steerable Needle
Manufacturer
Serpex Medical, Inc.
Date Cleared
2022-08-25
(121 days)
Product Code
KTI
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Serpex Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Compass Steerable Needle is a steerable biopsy needle intended be used through a compatible working channel bronchoscope or Medtronic Extended Working Channel (EWC) for the collection of tissue from the intrapulmonary regions.
Device Description
The Compass Steerable Needles (CSN) are sterile, single use, 22-gauge needles with a unidirectional, steerable distal tip for the acquisition of tissue from the intrapulmonary regions. The Steerable Needle consists of a handle, shaft, and needle. The handle provides the user with control of device rotation, extension, retraction, distal tip articulation of 70°±10° unidirectionally within a plane and a sampling mechanism to extend and retract the needle out of the shaft to obtain tissue samples. A Luer connector on the proximal end of the device provides the connection for the stylet or a syringe for aspiration during sampling. There are two models of the Compass Steerable Needle. Model CSN1001 can be coupled to Olympus® 190 or Pentax® bronchoscopes with a 2.0 working channel and 600 mm working length. It is packaged with a stylet, and adapters. Model CSN1002 can be coupled to the Medtronic Illumisite™ Extended Working Channel (EWC) with a 2.0 mm working channel. It is packaged with a stylet. The Compass Steerable Needles with stylet are inserted and coupled to either a bronchoscope or a Medtronic Illumisite EWC. The translation arm advances the device into the lung. Depressing the plunger articulates the distal end of the shaft. The sampling mechanism is depressed extending the needle to obtain a sample.
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K Number
K221302Device Name
Recon Steerable Sheath
Manufacturer
Serpex Medical, Inc.
Date Cleared
2022-08-15
(102 days)
Product Code
EOQ, REG
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Serpex Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Recon Steerable Sheath is an extended working channel intended to be used with a compatible bronchoscope to guide endotherapy accessories to the target area within the respiratory system.
Device Description
The Recon Steerable Sheath is a sterile, single use transbronchial sheath with a unidirectional, steerable distal tip that provides access to the intrapulmonary regions. It is designed to guide endotherapy tools with an outer diameter of up to 1.9 mm and minimum length of 1100 mm to the target tissue. The Recon Steerable Sheath (Model RSS1000) includes the Steerable Sheath, Stylet, Bronchoscope Adapter and Pentax Adapter. The Recon Steerable Sheath is compatible with Olympus® 190 or Pentax® bronchoscopes that have a 2.8mm working channel and 600 mm working length. It is coupled to the selected bronchoscope using an adapter(s). The handle provides the user with control of device rotation, extension, retraction, and distal tip articulation of 90° minimum within a plane with the stylet inserted. A Luer connector on the proximal end of the device provides the connection for the stylet. The Recon Steerable Sheath with stylet is inserted and coupled to a bronchoscope via a clip on the handle. The telescope advances the device beyond the bronchoscope into the lung. Depressing the plunger articulates the distal end of the sheath by tensioning an internal pull wire. Once in the desired location, the Stylet is removed from the Steerable Sheath and the tool of choice can be inserted for access.
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