Electrosurgical Disp. Dispersive Pad

FDA 510(k) K820196 · Promedicon, Inc.

Substantially Equivalent

510(k) numberK820196

Submission

Device name
Electrosurgical Disp. Dispersive Pad
Applicant
Promedicon, Inc.
Mchenry, IL, US
Received
January 25, 1982
Decision date
February 12, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4300
Specialty
Gastroenterology, Urology

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K262460Rezum SystemKNS · Traditional Boston Scientific09/03/2026SE
K260962SphincterotomeKNS · Traditional Taewoong Medical Co., Ltd.05/21/2026SE
K252388Vanquish Water Vapor Ablation DeviceKNS · Traditional Francis Medical, Inc.11/26/2025SE
K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)KNS · Traditional Olympus Medical Systems Corporation11/25/2025SE
K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use…KNS · Traditional Olympus Medical Systems Corp.10/17/2025SE
K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…KNS · Traditional Olympus Medical Systems Corporation10/10/2025SE
K251104SureTome™ SW Sphincterotome with DomeTipKNS · Traditional Wilson-Cook Medical09/29/2025SE
K251226Aqua Medical RF Vapor Ablation SystemKNS · Traditional Aqua Medical, Inc.08/08/2025SE
K250584Rezum SystemKNS · Traditional Boston Scientific Corporation06/11/2025SE
K242774SpydrBlade Flex Instrument (PRD-RG1-001)KNS · Traditional Creo Medical, Ltd.06/06/2025SE

More from Creo Medical, Ltd.

510(k)DeviceDecision
K820405Ground Aid CaphesiveKNS · Traditional 03/02/1982SE
K813434Electrosurgical Disp. Dispersive PadKNS · Traditional 01/12/1982SE

Questions and answers

When was Electrosurgical Disp. Dispersive Pad cleared by the FDA?

Electrosurgical Disp. Dispersive Pad (K820196) received a 510(k) decision of Substantially Equivalent on February 12, 1982, 18 days after the submission was received.

What is the product code of K820196?

The FDA product code is KNS – Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.4300.