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510(k) Data Aggregation
K Number
K232601Device Name
BroncTru Transbronchial Access Tool
Manufacturer
Date Cleared
2024-05-31
(277 days)
Product Code
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Broncus Medical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BroncTru Transbronchial Access Tool is indicated for use in conjunction with a flexible bronchoscope to puncture the lung, dilate, and establish a working channel, facilitating the guidance of other endoscopic tools to reach target lesions.
Device Description
The BroncTru Transbronchial Access Tool is a single-use sterile disposable catheter made up of four (4) components:
- i) Needle - used for puncturing of the transbronchial wall.
- ii) Dilator - the long-tapered tip dilator is used to dilate the opening in the transbronchial wall created by the needle. It also provides protection around the sharp needle tip during vascular access.
- iii) Sheath - the sheath inserted into the dilated tracheobronchial wall, provides a port through which a variety of endoscopic tools can be inserted.
- iv) Handle - The handle is operated by the operator to advance and to pull the dilator out leaving only the sheath to guide other devices to the target.
The BroncTru Transbronchial Access Tool is designed to puncture the tracheobronchial wall, the long-tapered tip of the dilator acts to stretch the opening in the tracheobronchial wall to allow for the insertion of the larger sheath. The dilator is then removed, leaving only the sheath inserted into the tracheobronchial wall, providing a channel which allows for subsequent endoscopic tool placement. This allows for access to lesions without a bronchus sign (outside the airways).
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K Number
K232038Device Name
BioStar Single Use Transbronchial Aspiration Needle
Manufacturer
Date Cleared
2024-04-26
(291 days)
Product Code
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Broncus Medical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K200702Device Name
EasyPath RF Introducer Sheath
Manufacturer
Date Cleared
2021-01-14
(302 days)
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Broncus Medical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EasyPath RF Introducer Sheath is a single-use device intended to be used with flexible bronchoscopes as a working channel through which endoscopic tools may be introduced to target tissue. It is indicated for electrosurgical procedures involving cutting and coagulation of soft tissue in the upper airways and tracheobronchial tree.
Device Description
The EasyPath RF Introducer Sheath is a sterile, single-use, monopolar endoscopic device intended to be inserted through the working channel of a flexible bronchoscope, with an inner diameter (ID) of 2.8 mm or greater, which provides an extended working channel through which endoscopic tools, such as needles, biopsy forceps, or other endoscopic devices may be introduced to target sites. Similar to Empower RF Catheter, the EasyPath incorporates a distal electrode for delivering RF energy for cutting and coagulation of soft tissue in the upper airways and tracheobronchial tree. The monopolar electrode at the distal tip facilitates cutting the target tissue using controlled monopolar radiofrequency (RF) energy.
The EasyPath has a flexible shaft with a 2.65 mm OD with braid reinforced tubing and a stylet, to resist kinking during device advancement and articulation. The stylet is used to provide an atraumatic tip and to provide rigidity (i.e., pushability). Removal of the stylet allows for standard 2.0 mm working channel bronchoscopic accessories to be inserted through the lumen of the sheath. The electrode tip of the sheath is visible, as well as the marker bands to provide the user with an indication of movement relative to the bronchoscope. Radiopaque markers are at the distal end of the sheath to aid visualization of the sheath under fluoroscopy, if utilized.
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K Number
K183240Device Name
Empower RF Catheter
Manufacturer
Date Cleared
2019-02-22
(94 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Broncus Medical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Empower RF Catheter is a single-use, electrosurgical device designed to be used with flexible bronchoscopes. It is indicated for electrosurgical procedures involving soft tissue obstructions in the upper airways and tracheobronchial tree.
Device Description
The Empower RF Catheter is a sterile, single-use monopolar endoscopic device intended to be inserted through a flexible bronchoscope or a working channel of a flexible bronchoscope with an inner diameter of 2.0 mm. It has a stainless-steel electrode at the distal end, a flexible catheter shaft comprised of a nitinol wire covered by insulation tubing to prevent kinking and facilitate pushability during bronchoscopic procedures and a standard male banana plug at the proximal end. The banana plug connects to a monopolar connecting cable of a compatible electrosurgical unit. Empower is activated by a footswitch accessory supplied with the electrosurgical unit. Empower is provided in a monopolar configuration and thus, must be used in conjunction with a commercially available compatible patient return electrode to complete the return path for the RF electrical current.
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