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Found 4 results
510(k) Data Aggregation
K Number
K241874Device Name
Aspiration Catheter (2189)
Manufacturer
Hobbs Medical, Inc.
Date Cleared
2024-09-24
(88 days)
Product Code
OCX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Hobbs Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be utilized by a trained physician through a flexible endoscope for the collection of duodenal or jejunal fluids for diagnostic analysis.
Device Description
The Hobbs Medical Aspiration Catheter is a sheath within a sheath design. The inner sheath is actuated using a proximal handle. The inner sheath is protected by an elastomeric membrane that has a slit at the distal end to allow for the inner sheath to advance. The inner sheath has three side holes at the distal tip for collection of aspirate. Once the sample is collected the inner sheath is retracted to protect the sample from contamination as it is withdrawn from the endoscope.
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K Number
K182927Device Name
Pulmonary Cytology Brush
Manufacturer
Hobbs Medical, Inc.
Date Cleared
2020-02-07
(473 days)
Product Code
BTG
Regulation Number
874.4680Why did this record match?
Applicant Name (Manufacturer) :
Hobbs Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pulmonary Cytology Brush is intended to allow brush sampling of tissue or cells from the upper or lower respiratory tract and/or to perform surveillance cultures
Device Description
Not Found
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K Number
K093079Device Name
TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U
Manufacturer
HOBBS MEDICAL, INC.
Date Cleared
2010-08-02
(306 days)
Product Code
KNS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
HOBBS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TouchSoft™ Coagulator is used to provide therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.
Device Description
Not Found
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K Number
K030765Device Name
HOBBS MISTIFIER SPRAY CATHETER
Manufacturer
HOBBS MEDICAL, INC.
Date Cleared
2003-06-09
(90 days)
Product Code
OCX, EOQ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
HOBBS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hobbs spray catheter is intended for use as a flexible endoscopic accessory to apply legally marketed solutions for washing or staining mucosal tissue.
Device Description
Not Found
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