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Electrosurgical Disp. Dispersive Pad

by Promedicon, Inc. 2 variants

510(k) K820196

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820196 Date12 Feb 1982ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KNS
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

An electrosurgical dispersive pad is a device used to safely return electrical current from the patient to the electrosurgical generator during procedures. It is designed to disperse the current over a broad area to prevent tissue damage at the return site.

This device is supplied as a disposable, single-use pad and is indicated for use in gastroenterology and urology procedures. It received FDA 510(k) clearance (K820196) on February 12, 1982, as substantially equivalent to a legally marketed device, and is classified as a Class II medical device under regulation number 876.4300.

Other devices from Promedicon, Inc.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the ELECTROSURGICAL DISP. DISPERSIVE PAD used for?

    The ELECTROSURGICAL DISP. DISPERSIVE PAD is used to safely return electrical current from the patient to the electrosurgical generator during procedures. It disperses the current over a broad area to prevent tissue damage at the return site, and is indicated for use in gastroenterology and urology procedures.

  • Is the ELECTROSURGICAL DISP. DISPERSIVE PAD disposable or reusable?

    The ELECTROSURGICAL DISP. DISPERSIVE PAD is supplied as a disposable, single-use pad, meaning it is intended for one-time use only and should be discarded after each procedure to ensure patient safety and prevent cross-contamination.

  • What regulatory pathway was used for the ELECTROSURGICAL DISP. DISPERSIVE PAD?

    The ELECTROSURGICAL DISP. DISPERSIVE PAD received FDA 510(k) clearance (K820196) on February 12, 1982, as substantially equivalent to a legally marketed device, and is classified as a Class II medical device under regulation number 876.4300.