Home / 510(k) Clearances / K974279

510(k) K974279

3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C) by 3M Healthcare — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1998
Date Received
November 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by 3M Healthcare

  • K193110 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (March 13, 2020)
  • K191355 — 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Ma (September 11, 2019)
  • K180874 — 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face S (July 31, 2018)
  • K180404 — 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System (March 16, 2018)
  • K171116 — 3M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/18 (August 10, 2017)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K140250 — 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE (July 25, 2014)
  • K974445 — 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 (July 26, 1998)
  • K980732 — 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT (May 15, 1998)

Other clearances for product code GEI

  • K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) (March 2, 2026)
  • K260287 — SP Electrocautery Device (SP20) (February 24, 2026)
  • K251813 — CURIS II RF Generator (REF 360100-05) (February 11, 2026)
  • K251836 — Dermatrix Duo (February 6, 2026)
  • K254290 — ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+ (January 30, 2026)
  • K254220 — Reusable 3 Button Fingerswitch Wand (January 27, 2026)
  • K251435 — InbellaIgnite RF System (January 27, 2026)
  • K251254 — Ignite RF System (January 15, 2026)
  • K251996 — ENTire IRE System (January 14, 2026)
  • K251988 — Boston iFace (Boston iFace) (January 12, 2026)