3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130)— 510(k) K974553
Substantially Equivalent3M Healthcare
FDA 510(k) clearance K974553 for 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130), Substantially Equivalent on 1998-02-03. Applicant: 3M Healthcare. Device class: 2.
Clearance details
- Applicant
- 3M Healthcare
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code GEI
view allMore clearances from 3M Healthcare
view all- K193110 — 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
- K191355 — 3M High Fluid-Resistant Surgical Mask and 3M High Fluid-Resistant Procedure Mask
- K180874 — 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
- K180404 — 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
- K171116 — 3M VFlex Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.