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510(k) Data Aggregation
K Number
K243190Device Name
USTOMED Bone Fixation/Bone Augmentation Systems - PIN
Manufacturer
Ustomed Instrumente Ulrich Storz GmbH & Co. KG
Date Cleared
2025-06-27
(270 days)
Product Code
DZL
Regulation Number
872.4880Why did this record match?
Applicant Name (Manufacturer) :
Ustomed Instrumente Ulrich Storz GmbH & Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
USTOMED Bone Fixation/Bone Augmentation Systems – PIN is intended for fastening membranes during bone regenerative treatment.
Device Description
USTOMED Bone Fixation/Bone Augmentation Systems – PIN consists of a titanium pin. The Pin can be used to fasten third-party non-absorbable PTFE and titanium-reinforced membranes up to a thickness of 1.0mm cleared by FDA for stabilization and support of bone grafts in dento-alveolar bony defect sites (product code JEY). After fulfilling its supportive function, which is typically achieved within three to nine months, the Pin must be removed, as it is not intended to remain in the body permanently.
The Pin are intended for single use and provided non-sterile for cleaning and sterilization by the user before use.
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K Number
K243550Device Name
KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
Manufacturer
KARL STORZ SE & CO. KG
Date Cleared
2025-06-06
(203 days)
Product Code
FGB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
KARL STORZ SE & CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ Flexible Video-Uretero-Renoscope is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
Device Description
The KARL STORZ Flexible Video-Uretero-Renoscope (PNs 11278VSE, 11278VSUE) is a video endoscope used for visualization within the upper urinary tract (ureters) and kidneys. The endoscope includes a luer with two ports to allow access for instrumentation, as well as irrigation. The Flexible Video-Uretero-Renoscope models 11278VSE and 11278VSUE differ only in the direction of the distal tip deflection. With 11278VSUE when the control lever is pushed forward towards the distal tip, the distal tip deflects down and with 11278VSE the deflection is opposite.
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K Number
K244001Device Name
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
Manufacturer
KARL STORZ SE & CO. KG
Date Cleared
2025-05-02
(127 days)
Product Code
FBO
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
KARL STORZ SE & CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ Cysto-Urethro-Fiberscope and accessories are indicated for visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.
Device Description
The KARL STORZ Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11272CU1 / 11272C2) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.
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K Number
K243409Device Name
KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
Manufacturer
KARL STORZ SE & CO. KG
Date Cleared
2024-11-27
(26 days)
Product Code
FBO
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
KARL STORZ SE & CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
Device Description
The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11274BCU1) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
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K Number
K240506Device Name
KARL STORZ Holders
Manufacturer
KARL STORZ Endoscopy America, Inc
Date Cleared
2024-10-22
(244 days)
Product Code
OCV, GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
KARL STORZ Endoscopy America, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc) and accessories during general and neurologic diagnostic and therapeutic procedures.
Device Description
The KARL STORZ Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, arthroscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the several KARL STORZ holding systems, which are a Class 1, table-mounted, mechanical and electromechanical holding arms that have many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.
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K Number
K241945Device Name
KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)
Manufacturer
KARL STORZ SE & CO. KG
Date Cleared
2024-08-01
(29 days)
Product Code
FGB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
KARL STORZ SE & CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
Device Description
The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Numbers: 11278ACU1 and 11278AC2) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
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K Number
K233372Device Name
KARL STORZ Fiber Telescopes for Urology
Manufacturer
Karl Storz SE & Co. Kg
Date Cleared
2024-07-25
(297 days)
Product Code
FGB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Karl Storz SE & Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K232911Device Name
KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)
Manufacturer
Karl Storz Endovision, Inc
Date Cleared
2024-06-10
(265 days)
Product Code
FGB
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Karl Storz Endovision, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ Flexible Uretero-Reno-Fiberscope is indicated for examination of the upper urinary tract including the ureter and kidneys and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Device Description
The optical component of the KARL STORZ flexible ureteroscope consists of:
• A light post connection with screw-on adapters for fiberoptic light cables.
• A fiber optic light conductor
• An optical image bundle behind an objective lens
• A flexible shaft housing
• A magnifying eyepiece with a focusing ring that rotates to adjust to the appropriate diopter correction for the user
• A reticle, or marker in the field of view, that indicates the 12 o'clock position as a point of reference
The insertable portion of the instrument is divided into a flexible shaft section and a deflection section. The features of the shaft include:
• A working channel that accepts flexible accessories at the proximal end and features a T-LUER Lock fitting for irrigation
• A deflection lever, for active distal tip deflection
• A proximal strain relief that connects the flexible shaft to the handpiece
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K Number
K232486Device Name
KARL STORZ Monopolar Resectoscopes with HF Cable
Manufacturer
Karl Storz SE & CO. KG
Date Cleared
2024-05-07
(265 days)
Product Code
FJL, FAS, FBO, FDC, HIH
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Karl Storz SE & CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K232370Device Name
Percutaneous Nephroscope System
Manufacturer
Karl Storz SE & Co. Kg
Date Cleared
2024-05-01
(267 days)
Product Code
FGA
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Karl Storz SE & Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Percutaneous System for adults
The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults.
Percutaneous System for adults and pediatrics
The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults and pediatrics >1month of age.
Device Description
The Percutaneous Nephroscope System consists of the following:
- Minimally Invasive Percutaneous Nephrolithopaxy (MIP) Nephroscopes
- HOPKINS Telescopes for Percutaneous Nephrolithotomy (PCNL)
- Operating Sheaths
- One-Step Dilators
- Telescope Bougie Set
- Hollow Obturator and Fascial Dilator Applicators
- Biopsy and Grasping forceps
- Scissors
- Knives
- Insertion Aid
- Laser Hand Instrument
- Suction tube
- Adaptors
- Luer-Lock tube connectors
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