FDA.reportPublic FDA data

510(k) K221929

Device
Smith+Nephew INTELLIO Tablet
Applicant
Smith+Nephew
510(k) number
K221929
Product code
ODA
Decision
Substantially Equivalent (SESE)
Decision date
2022-09-06
Date received
2022-07-01
Regulation
876.1500
Classification name
Endoscopic Central Control Unit
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kathleen Solomon
Address
150 Minuteman Rd. Andover MA US 01810 01810

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K080410KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522KARL STORZ Endoscopy-America, Inc.2008-04-09
K070827KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120KARL STORZ Endoscopy-America, Inc.2007-05-22
K051613MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3Olympus Medical Systems Corporation2005-08-15
K041912SCB/VALLEYLAB FORCE FX INTERFACE UNITKARL STORZ Endoscopy-America, Inc.2004-10-25
K020255RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590Richard Wolf Medical Instruments Corp.2002-09-18
K022270MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHAOlympus Optical Co., Ltd.2002-08-14