HotDog Warming Mattress + Return Electrode
FDA 510(k) clearance K210727 · decided 2022-02-01
Clearance details
- K-number
- K210727
- Device name
- HotDog Warming Mattress + Return Electrode
- Applicant
- Augustine Temperature Management, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-03-11
- Decision date
- 2022-02-01
- Days to decision
- 327 days
- Clearance type
- Abbreviated
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 use recall (Z-1171-2025) | Augustine Temperature Management, LLC | 2025-02-14 |
| Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 use recall (Z-1172-2025) | Augustine Temperature Management, LLC | 2025-02-14 |