# K974553: 3M Universal Electrosurgical Pad, Split (9160) 3M Universal Electrosurgical Pad (9130)

- Pathway: 510(k) (Traditional)
- Applicant: 3M Healthcare
- Decided: Feb 3, 1998 after 78 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
3M™ Universal Electrosurgical Pads are designed to work with most electrosurgical units (ESU’S) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split style Universal Electrosurgical Pad is for use with ESUs that have a CQMS (i.e. REM, ARM, NESSY etc.). The 3M™ Universal Electrosurgical Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this product. Use of this product for unintended applications could lead to an unsafe condition.

Source page: https://510kreport.com/device/K974553
Methodology: https://510kreport.com/methodology