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510(k) Data Aggregation
K Number
K082010Device Name
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
Manufacturer
STRYKER IRELAND LTD., INSTRUMENTS DIVISION
Date Cleared
2008-12-29
(167 days)
Product Code
HBF
Regulation Number
882.4305Why did this record match?
Applicant Name (Manufacturer) :
STRYKER IRELAND LTD., INSTRUMENTS DIVISION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Stryker Zyphr ™ Disposable Cranial Perforator Large 14/11mm (perforator) is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. It is intended for thin bone that is at least 3mm thick.
The Stryker Zyphr ™ Disposable Cranial Perforator Small 11/7mm (perforator) is a sterile, single use cutting accessory intended for cutting a 7 mm diameter access hole through the cranium of adult and pediatric patients. It is intended for thin bone that is at least 1mm thick.
Device Description
The Zyphr TM Disposable Cranial Perforator is a mechanically powered tool specifically designed to rapidly create an access hole through the skull in a safe and reliable manner.
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K Number
K073633Device Name
STRYKER ESSX MICRODEBRIDER SYSTEM
Manufacturer
STRYKER IRELAND LTD., INSTRUMENTS DIVISION
Date Cleared
2008-08-26
(244 days)
Product Code
ERL
Regulation Number
874.4250Why did this record match?
Applicant Name (Manufacturer) :
STRYKER IRELAND LTD., INSTRUMENTS DIVISION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ESSx Microdebrider System is intended for the cutting and removal of soft and osseous tissue in general ENT encompassing the areas of Sinus, Nasopharyngeal /Laryngeal and Head and Neck procedures, such as the following:
Sinus:
- ethmoidectory/sphenoethmoidectomy
- polypectomy
- septoplasty
- antrostomy
- endoscopic DCR
- frontal sinus drill-out
- frontal sinus trephination
- septal spurs removal
- trans-sphenoidal procedures
Nasopharyngeal/laryngeal:
- adenoidectomy
- laryngeal lesion debulking
- laryngeal polypectomy
- tracheal procedures
- tonsillectomy
Head & Neck:
- soft tissue shaving
- rhinoplasty
- removal of fatty tissue in the maxillary and mandibular regions of the face
Device Description
The Stryker ESSx Microdebrider System is a powered instrument system consisting of a console, footswitch, handpiece, irrigation cassette, and a variety of disposable shaver accessories.
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