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510(k) Data Aggregation
K Number
K153763Device Name
Howell Biliary Aspiration Needle
Manufacturer
WILSON-COOK MEDICAL, INC.
Date Cleared
2017-04-06
(463 days)
Product Code
FCK
Regulation Number
876.1075Why did this record match?
Product Code :
FCK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for aspiration biopsy in the biliary system.
Device Description
The Howell Biliary Aspiration Needle is a sterile, single use device that consists of a luer slip handle with adjustment wheel, outer catheter sheath, needle catheter with needle, stylet and winged hub. The device is compatible with endoscopes with a minimum accessory channel of 2.8 mm. The Howell Biliary Aspiration Needle is 200 cm long. The catheter is comprised of PTFE while the needle is stainless steel and the stylet is nitinol.
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K Number
K103326Device Name
MULTIPLE BIOPSY SYSTEM
Manufacturer
UNITED STATES ENDOSCOPY GROUP, INC.
Date Cleared
2011-04-06
(145 days)
Product Code
FCK
Regulation Number
876.1075Why did this record match?
Product Code :
FCK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Multiple Biopsy System is intended to be used with a suction source to collect biopsy samples from the upper and lower gastrointestinal tract for microscopic examination.
Device Description
Not Found
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K Number
K062159Device Name
RB12 SUCTION RECTAL BIOPSY SYSTEM
Manufacturer
AUS SYSTEMS PTY LTD.
Date Cleared
2006-09-05
(39 days)
Product Code
FCK
Regulation Number
876.1075Why did this record match?
Product Code :
FCK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RB12 Suction Rectal Biopsy System is intended to provide biopsy specimens of the rectal mucosa and submucosa suitable for pathological examination for the diagnosis of Hirschsprung's disease.
Device Description
The RB12 consists of a gamma sterilized single use polystyrene closed end cylinder shaped capsule with a small hole at the closed end which contains a stainless steel cutting blade and a polyethylene seal. The capsule connects to a re-useable handpiece (HP1000) via a quick twist and lock system and suits both left and right handed operators. The HP1000 has an inner piston which automatically locates in the internal seal when the capsule is connected. This creates an airtight loop to the attached syringe via the suction tube/syringe adaptor. The inner piston is pushed forward when the thumb trigger is activated pushing the blade forward past the capsule hole cutting the specimen. The RBI2 design uses a combination of a re-useable handpiece and a disposable (single use) capsule. The capsule is supplied to the end users in a sterile state completely assembled with an internal blade and seal. A syringe is connected to the rear end of the internal trigger tube via a piece of suction tube and a syringe/tube adaptor (supplied sterile with capsules). The disposable is placed onto the outer tubing that is housed within the handle. While placing the capsule the internal trigger tube automatically locates and passes through the seal. When capsule is placed onto the handpiece it creates an air loop from the syringe to the front section of the capsule. The capsule is placed against the mucosal wall of the rectum of the patient covering the capsule port. When the syringe is withdrawn this causes negative pressure in the capsule sucking the mucosal and sub mucosal into the capsule. The thumb trigger is pushed forward which pushes the blade forward cutting the tissue that has been sucked into the port. The front of the capsule remains airtight as the trigger/inner tube slides through the internal seal.
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K Number
K061201Device Name
DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
Manufacturer
UNITED STATES ENDOSCOPY GROUP, INC.
Date Cleared
2006-05-30
(29 days)
Product Code
FCK
Regulation Number
876.1075Why did this record match?
Product Code :
FCK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The dSnare Diminutive Polypectomy and Suction System is a non-diathermic device with a suction retrieval feature indicated for transendoscopic polypectomy and suction retrieval of lesions between 3mm and 7mm in size.
Device Description
The dSnare Diminutive Polypectomy and Suction System is a non-diathermic device with a suction retrieval feature.
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K Number
K051637Device Name
DSNARE, MODEL 00711087
Manufacturer
UNITED STATES ENDOSCOPY GROUP, INC.
Date Cleared
2005-10-31
(133 days)
Product Code
FCK
Regulation Number
876.1075Why did this record match?
Product Code :
FCK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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