3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C)
FDA 510(k) clearance K974279 · decided 1998-01-30
Clearance details
- K-number
- K974279
- Device name
- 3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C)
- Applicant
- 3M Healthcare
- Decision
- Substantially Equivalent
- Date received
- 1997-11-14
- Decision date
- 1998-01-30
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D recall (Z-3017-2024) | MEDLINE INDUSTRIES, LP - Northfield | 2024-09-06 |
| 3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165 recall (Z-1608-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |
| 3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgi recall (Z-0701-2017) | 3M Company - Health Care Business | 2016-12-03 |