KARL STORZ Monopolar Resectoscopes with HF Cable

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Electrical-only medical device connection cable, reusable

Device Name

HF cables

Model / Reference

26176LV, 26006ML, 26002ML, 277A, 26176LVL, 26002M, 26176LW, 26004M, 847000M, 847000V, 277KB, 279KE, 847002V, UH801, 26176LEL, 26176LML, 26002MR, 26004ML, 26176LER

Primary DI / UDI-DI

04048551100363, 04048551090930, 04048551090299, 04048551090114, 04048551100387, 04048551090237, 04048551348017, 04048551090749, 04048551209226, 04048551209240, 04048551090169, 04048551090909, 04048551209295, 04048551388778, 04048551100288, 04048551100325, 04048551430934, 04048551090756, 04048551430941

Basic UDI-DI

4048551000505TF

510(k) Number

K232486 ↗

FDA Product Code

FJL 510(k)

GEI GUDID

EOB GUDID

EMDN Code

Z12010980 Electrosurgery instruments - hardware accessories

GMDN Term

Electrical-only medical device connection cable, reusable

Device Class

Class I EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 876.1500 510(k)

878.4400 GUDID

874.4760 GUDID

EU market of registration

Germany

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

• Karl Storz Supraloop

  Class II

  FDA 510(k) K254303 Active Cleared 24 Sep 2026

• n.a. 791003DS

  Class I

  GUDID on market

• n.a. 268015

  Class II

  GUDID on market

• n.a. 744101

  Class I

  GUDID on market

• n.a. 28163ZSH

  Class II

  GUDID on market

• n.a. 11603ZS

  Class II

  GUDID on market

See all devices from Karl Storz SE & CO. KG →

• Are these resectoscopes intended for single-use or reusable procedures, and what does that mean for maintenance and cleaning?

  The Karl Storz Monopolar Resectoscopes with HF Cable are designed as reusable medical devices, meaning they are meant for repeated use in controlled clinical settings like operating rooms or endoscopy suites. Since they are reusable, proper cleaning, sterilization, and maintenance are critical to ensure patient safety and device performance. The manufacturer provides specific guidelines for these processes, which must be strictly followed to prevent contamination or damage to the equipment.

• What specialties are these resectoscopes primarily used in, and how does their design support those procedures?

  These resectoscopes are primarily intended for use in gastroenterology and urology, as indicated by their regulatory classification and advisory committee designation. Their design incorporates high-frequency (HF) current capabilities, allowing for precise tissue resection and coagulation during minimally invasive procedures. This makes them suitable for complex interventions in these specialties, such as polypectomy or bladder tumor removal, where controlled cutting and sealing of blood vessels are essential.

• How many different model references are available, and what does this variety mean for clinical flexibility?

  The Karl Storz Monopolar Resectoscopes come in multiple model references, as evidenced by the listed FEI numbers (e.g., 3006546082, 1000208608, etc.). This variety allows clinicians to select a model best suited for specific procedural needs, such as varying tissue types, anatomical sites, or surgical techniques. The different models ensure compatibility with high-frequency generators and may offer variations in shaft length, tip design, or channel configurations to enhance precision and adaptability in both urology and gastroenterology.

• What regulatory pathways have these resectoscopes undergone, and how does that affect their use in clinical settings?

  The device has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR), ensuring it meets stringent safety and performance standards. This regulatory approval indicates that the resectoscopes have been evaluated for substantial equivalence to predicate devices and adhere to manufacturing, labeling, and post-market surveillance requirements. Clinicians can rely on these approvals to confirm the device’s compliance with global regulatory expectations, though local institutional protocols for use and maintenance remain mandatory.

• Are there specific storage requirements for these resectoscopes to maintain their functionality and sterility?

  While the provided data does not detail exact storage conditions, as reusable devices, these resectoscopes must be stored in a clean, dry environment to prevent contamination or damage between uses. After cleaning and sterilization, they should be kept in a designated storage area, away from direct sunlight or extreme temperatures, to preserve their structural integrity and operational readiness. Adherence to the manufacturer’s guidelines for storage is essential to ensure longevity and reliability in clinical settings.