E1070 & E1080 Series Reusable LLETZ Electrodes

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K921885 ↗

FDA Product Code

HGZ

Device Class

Class II

Regulation

21 CFR Part 884.5390

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from Valleylab, Inc. →

• Are these electrodes intended for repeated use in multiple patients, or are they meant to be single-use only despite being labeled as reusable?

  The E1070 & E1080 Series Reusable LLETZ Electrodes are designed for single-use per patient procedure, even though they are labeled as reusable. This means they should not be reused on different patients, but they are engineered to withstand repeated sterilization cycles for reuse within the same facility. Strict adherence to sterilization protocols is required to maintain safety and functionality.

• How are these electrodes supplied, and do they come pre-sterilized?

  The electrodes are supplied sterile by Valleylab, Inc., ensuring they are ready for immediate use in a clinical setting. This eliminates the need for initial sterilization before the first use, but they must still follow proper sterilization protocols between uses within the same facility, as they are intended for repeated sterilization cycles.

• What types of procedures are these electrodes specifically designed for, and why?

  These electrodes are specifically designed for Large Loop Excision of the Transformation Zone (LLETZ) procedures, a technique used in obstetrics and gynecology to remove abnormal cervical tissue under direct visualization. The electrode’s shape and design are optimized for precision cutting and coagulation during this procedure, ensuring effective tissue removal while minimizing damage to surrounding healthy tissue.

• What regulatory pathway did these electrodes follow to gain market authorization, and what does that mean for their use?

  The E1070 & E1080 Series Reusable LLETZ Electrodes followed the FDA 510(k) clearance process, specifically under the Obstetrics/Gynecology advisory committee. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for its intended use in LLETZ procedures. The clearance (K921885) confirms compliance with regulatory requirements for Class II devices.