Kit, Nephroscope
Gastroenterology, Urology · 21 CFR 876.1500
Recent MDR events
96 adverse event reports on file
- OUTER SHEATH, 25FR., ROTATABLE, CONTINUOUS FLOWJul 10, 2026MalfunctionOlympus Winter & Ibe Gmbh9610773-2026-04874
- HOPKINS TELESCOPE 6°, 18 FR.Jun 17, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01404
- HOPKINS TELESCOPE 6°, 18 FR.Jun 17, 2026InjuryKarl Storz Se & Co. Kg2020550-2026-01403
- HOPKINS TELESCOPE 6°, 18 FR.Jun 17, 2026InjuryKarl Storz Se & Co. Kg9610617-2026-01403
- OP-TELESCOPE, 30°, 4 MM CHANNELMay 23, 2026MalfunctionOlympus Winter & Ibe Gmbh9610773-2026-03980
- OP-TELESCOPE, 30°, 4 MM CHANNELMay 6, 2026MalfunctionOlympus Winter & Ibe Gmbh9610773-2026-03594
- OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULARApr 13, 2026MalfunctionOlympus Winter & Ibe Gmbh9610773-2026-02946
- OP TELESCOPE, 7°, 11 FR. X 220 MM, 7.5 FR. CHANNEL, ANGLED OCULARFeb 24, 2026MalfunctionOlympus Winter & Ibe Gmbh9610773-2026-01423
- OP-TELESCOPE, 30°, 4 MM CHANNELJan 5, 2026MalfunctionOlympus Winter & Ibe Gmbh9610773-2026-00042
- OP-TELESCOPE, 30°, 4 MM CHANNELDec 30, 2025MalfunctionOlympus Winter & Ibe Gmbh9610773-2025-08556
Event type breakdown
Recalls
8 recall events for this product code
- Karl Storz EndoscopyOpen, ClassifiedSep 24, 2024
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Z-3218-2024 · View FDA record ↗ - Karl Storz EndoscopyOpen, ClassifiedSep 24, 2024
Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Z-3219-2024 · View FDA record ↗ - Karl Storz EndoscopyOpen, ClassifiedSep 24, 2024
Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Z-3220-2024 · View FDA record ↗ - Karl Storz EndoscopyOpen, ClassifiedSep 24, 2024
Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Z-3221-2024 · View FDA record ↗ - Karl Storz EndoscopyOpen, ClassifiedSep 24, 2024
Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Z-3222-2024 · View FDA record ↗ - Karl Storz EndoscopyOpen, ClassifiedSep 24, 2024
Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Z-3223-2024 · View FDA record ↗ - Karl Storz EndoscopyOpen, ClassifiedSep 24, 2024
Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Z-3224-2024 · View FDA record ↗ - Karl Storz EndoscopyOpen, ClassifiedSep 24, 2024
Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Z-3225-2024 · View FDA record ↗
Registered firms
52 firms currently registered for this product code
Josef Bacher Gmbh
Rietheim-Weilheim Baden-Wurttemberg, DE
Auris Health, Inc
Santa Clara, CA, US
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Isomedix Operations, Inc.
Temecula, CA, US
Arvato Se
Hamburg, DE
Schoelly Fiberoptic, Gmbh
DENZLINGEN Baden-Wurttemberg, DE
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Karl Storz Se & Co. Kg
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Richard Wolf Gmbh
KNITTLINGEN Baden-Wurttemberg, DE
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Karl Storz Endovision, Inc.
CHARLTON, MA, US
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Well Lead Medical Co. Ltd
GUANGZHOU Guangdong, CN
Boyd Weiler Gmbh & Co. Kg
Weiler-Simmerberg Bavaria, DE
Olympus Winter & Ibe Gmbh
HAMBURG, DE
Bentec Endoscopy Gmbh
Rietheim-Weilheim Baden-Wurttemberg, DE
Haager Gmbh & Co. Kg
Pforzheim Baden-Wurttemberg, DE
Storz Endoskop Produktions Gmbh
SCHAFFHAUSEN, CH
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Cook Incorporated
Spencer, IN, US
510(k) clearances
10 clearances for this product code
- Karl Storz SE & CO. KGMay 1, 2024
K232370 · Percutaneous Nephroscope System
- Schoelly Fiberoptic GmbHFeb 9, 2016
K151308 · Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
- Gyrus Acmi, Inc.Dec 13, 2007
K072594 · GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
- Richard Wolf Medical Instruments Corp.Jun 5, 2000
K994223 · NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20
- KARL STORZ Endoscopy-America, Inc.Mar 15, 1995
K950433 · KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES
- KARL STORZ Endoscopy-America, Inc.Sep 9, 1994
K940594 · KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE
- Optimed Technologies, Inc.Feb 19, 1993
K922826 · FLEXIBLE FIBER OPTIC ENDOSCOPE
- Olympus Corp.Sep 12, 1985
K853486 · OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE