Operio
FDA 510(k) clearance K153498 · decided 2016-07-20
Clearance details
- K-number
- K153498
- Device name
- Operio
- Applicant
- Toul Meditech AB
- Decision
- Substantially Equivalent
- Date received
- 2015-12-07
- Decision date
- 2016-07-20
- Days to decision
- 226 days
- Clearance type
- Traditional
- Product code
- ORC
- Device class
- 2
- Regulation number
- 878.5070
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Västerås, SE
- 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 |
|---|---|---|
| SteriStay (K190027) | Toul Meditech AB | 2019-05-10 |
| Operio (K173349) | Toul Meditech AB | 2017-12-20 |
| SurgiCube (K163455) | Surgicube International B.V. | 2017-09-28 |
| AIR BARRIER SYSTEM (ABS) (K123006) | Nimbic Systems, Inc. | 2013-12-20 |
| ABS BLOWER, ABS NOZZLE, MODEL 1001 (K092801) | Nimbic Systems, LLC | 2011-05-20 |
Recalls involving this device
No recalls on record reference this clearance.