BWP
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Shoe And Shoe Cover, Conductive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1999: 3 · 2005: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT (K880384) | Kimberly-Clark Corp. | 1988-06-23 |
| SURGICAL APPAREL SHOE COVERS (K831952) | Sudreca Surgical Dressings, Inc. | 1983-07-12 |
| ANOGO DISPOSABLE SHOE COVER (K812105) | Anago, Inc. | 1981-09-11 |
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Every clearance here is in the API, with alerts when new ones post.