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510(k) K190576

Device
WalterLorenz Surgical Assist Arm Scope Holder
Applicant
Biomet Microfixation
510(k) number
K190576
Product code
OCV  
Decision
Substantially Equivalent (SESE)
Decision date
2019-06-05
Date received
2019-03-06
Regulation
876.1500
Classification name
Endoscope Holder
Medical specialty
Gastroenterology/Urology
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lauren Jasper
Address
1520 Tradeport Dr. Jacksonville FL US 32218 32218

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OCV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240506KARL STORZ HoldersKarl Storz Endoscopy America, Inc.2024-10-22
K232405ENDOFIX EXOAktormed GmbH2024-04-25
K102179ENVIEW (TM)Carefusion 22002010-12-02
K093616V. MUELLER CAMERA CONTROLLER WITH STORAGE CARTCarefusion 22002009-12-23
K992006NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33Integra Neurocare, LLC1999-08-17
K990334KSEA ENDOSCOPE HOLDERKARL STORZ Endoscopy-America, Inc.1999-03-22
K971584CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)Clarus Medical Systems, Inc.1997-05-23
K960068SH-1 SURGICAL HOLDER FOR TELESCOPEOlympus America, Inc.1997-05-05
K810787UROLOGIC TUBE HOLDERThe Urology Group1981-03-31

Legacy Summary#

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FDA Review#

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