LapBox Power Tissue Containment System
FDA 510(k) clearance K250212 · decided 2025-04-15
Clearance details
- K-number
- K250212
- Device name
- LapBox Power Tissue Containment System
- Applicant
- Ark Surgical
- Decision
- Substantially Equivalent
- Date received
- 2025-01-24
- Decision date
- 2025-04-15
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- PMU
- Device class
- 2
- Regulation number
- 884.4050
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- 13 Wadi El Haj, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| More-Cell-System (K212659) | Agency For Medical Innovations GmbH | 2021-11-10 |
| PneumoLiner (K192898) | Advanced Surgical Concepts | 2020-02-25 |
| PneumoLiner (DEN150028) | Advanced Surgical Concepts, Ltd. | 2016-04-07 |
Recalls involving this device
No recalls on record reference this clearance.