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Delta Conductive Adhesive Electrosurg-

by Delta Medical Electronics, Inc. EUDAMED510(k)

Active European Union and United States

510(k) K832157

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK832157 Date26 Jul 1983ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Delta Conductive Adhesive Electrosurgical is a medical adhesive designed for use in electrosurgical procedures. It functions as a conductive interface between the patient’s skin and electrosurgical instruments, facilitating safe and effective tissue manipulation during surgery.

This device is supplied as a single-use adhesive and is classified under Product Code GEI, intended for general and plastic surgery applications. Authorized under FDA 510(k) clearance (K832157) and MDD compliance, it is intended for sterile use in controlled surgical environments. No MRI safety information or reusable specifications are provided.

Other devices from Delta Medical Electronics, Inc.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of surgical procedures is the Delta Conductive Adhesive Electrosurgical intended for, and how does it function during surgery?

    The Delta Conductive Adhesive Electrosurgical is designed for use in general and plastic surgery procedures, specifically as a conductive interface between the patient’s skin and electrosurgical instruments. It ensures safe and effective tissue manipulation by improving electrical conductivity, reducing resistance, and minimizing potential risks associated with electrosurgery, such as burns or inadequate current flow.

  • Is the Delta Conductive Adhesive Electrosurgical meant for single-use or repeated use in a surgical setting?

    This device is explicitly supplied as a single-use adhesive, meaning it is intended for one surgical procedure only. Reuse is not recommended or supported by the manufacturer, as repeated use could compromise sterility, performance, or patient safety.

  • How is the Delta Conductive Adhesive Electrosurgical packaged and stored, and is it sterile?

    The Delta Conductive Adhesive Electrosurgical is packaged for sterile use in controlled surgical environments. While the exact packaging details (e.g., pouch type, barrier materials) aren’t specified, its classification under Product Code GEI and FDA 510(k) clearance (K832157) imply it is terminally sterilized and intended for direct surgical application without additional sterilization steps. Storage should follow standard sterile supply protocols to maintain integrity until use.

  • What regulatory pathways does the Delta Conductive Adhesive Electrosurgical follow, and how does that affect its availability?

    The device is authorized through FDA 510(k) clearance (K832157) under the Traditional pathway, with a Substantially Equivalent (SESE) determination by the Surgical Devices Panel (SU). It also complies with the Medical Device Directive (MDD) in its original market. This means it is legally marketed in the U.S. and EU (or other MDD-compliant regions) for its intended surgical applications, though availability may depend on local regulatory approvals and distribution agreements.