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510(k) K232370

Device
Percutaneous Nephroscope System
Applicant
Karl Storz SE & CO. KG
510(k) number
K232370
Product code
FGA
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-01
Date received
2023-08-08
Regulation
876.1500
Classification name
Kit, Nephroscope
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
Alita McElroy
Address
Dr.-Karl-Storz-Straße 34 Baden-Wurttemberg Tuttlingen DE 78532 78532

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FGA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetSchoelly Fiberoptic GmbH2016-02-09
K072594GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEMGyrus Acmi, Inc.2007-12-13
K994223NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20Richard Wolf Medical Instruments Corp.2000-06-05
K950433KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURESKARL STORZ Endoscopy-America, Inc.1995-03-15
K940594KARL STORZ ADULT & PEDIATRIC NEPHROSCOPEKARL STORZ Endoscopy-America, Inc.1994-09-09
K922826FLEXIBLE FIBER OPTIC ENDOSCOPEOptimed Technologies, Inc.1993-02-19
K853486OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPEOlympus Corp.1985-09-12
K791182ACMI RIGI-FLEX NEPHORSCOPEAmerican Cystocope Makers, Inc.1979-07-30
K770729PYELOSCOPE SYSTEMRichard Wolf Medical Instruments Corp.1977-04-28