510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974279Substantially Equivalent

3M Universal Electrosurgical Pad, with Cord (Catalog Number 9135), 3M Universal Electrosurgical Pad, Split with Cord (C)

3M Healthcare, St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974279 is the FDA 510(k) clearance record for 3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C), a class II device, cleared for 3M Healthcare on under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "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...". FDA records list 21 510(k) clearances for 3M Healthcare, from to . As of , FDA records show 3 recalls naming K974279.

Clearance record

Decision date
Received
(77 days to decision)
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
3M Healthcare 3m Center, Bldg. 275-3e-08, St. Paul MN
510(k) summary
Summary
Third party review
No

Clearances, product code GEI

Trailing 12 months
47 clearances under product code GEI in the twelve months to October 2026, June 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code GEI, trailing twelve months
MonthClearances
November 20254
December 20251
January 20266
February 20263
March 20265
April 20265
May 20264
June 20269
July 20263
August 20262
September 20265
October 20260