ClearanceBrief
Panels › Gastroenterology, Urology › Product code FGA · Class 2

Kit, Nephroscope

Regulation 876.1500

0510(k)s in 12 months (10 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
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Top companies in FGA

Company510(k)sRecalls
Karl Storz Endoscopy08
KARL STORZ Endoscopy-America, Inc.20
Richard Wolf Medical Instruments Corp.20
American Cystocope Makers, Inc.10
Gyrus Acmi, Inc.10
Karl Storz SE & CO. KG10
Olympus Corp.10
Optimed Technologies, Inc.10
Schoelly Fiberoptic GmbH10
Decided510(k)Device and applicantCode
May 1, 2024K232370Percutaneous Nephroscope System
Karl Storz SE & CO. KG, DE
FGA
Feb 9, 2016K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
Schoelly Fiberoptic GmbH, DE
FGA
Dec 13, 2007K072594GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
Gyrus Acmi, Inc.
FGA
Jun 5, 2000K994223NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20
Richard Wolf Medical Instruments Corp.
FGA
Mar 15, 1995K950433KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES
KARL STORZ Endoscopy-America, Inc.
FGA
Sep 9, 1994K940594KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE
KARL STORZ Endoscopy-America, Inc.
FGA
Feb 19, 1993K922826FLEXIBLE FIBER OPTIC ENDOSCOPE
Optimed Technologies, Inc.
FGA
Sep 12, 1985K853486OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE
Olympus Corp.
FGA
Jul 30, 1979K791182ACMI RIGI-FLEX NEPHORSCOPE
American Cystocope Makers, Inc.
FGA
Apr 28, 1977K770729PYELOSCOPE SYSTEM
Richard Wolf Medical Instruments Corp.
FGA

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