PneumoLiner
FDA 510(k) clearance K192898 · decided 2020-02-25
Clearance details
- K-number
- K192898
- Device name
- PneumoLiner
- Applicant
- Advanced Surgical Concepts
- Decision
- Substantially Equivalent
- Date received
- 2019-10-11
- Decision date
- 2020-02-25
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- PMU
- Device class
- 2
- Regulation number
- 884.4050
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Bray, IE
- 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 |
|---|---|---|
| LapBox Power Tissue Containment System (K250212) | Ark Surgical | 2025-04-15 |
| More-Cell-System (K212659) | Agency For Medical Innovations GmbH | 2021-11-10 |
| PneumoLiner (DEN150028) | Advanced Surgical Concepts, Ltd. | 2016-04-07 |
Recalls involving this device
No recalls on record reference this clearance.