Acessa ProVu System
FDA 510(k) clearance K181124 · decided 2018-09-28
Clearance details
- K-number
- K181124
- Device name
- Acessa ProVu System
- Applicant
- Acessa Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-04-30
- Decision date
- 2018-09-28
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- HFG
- Device class
- 2
- Regulation number
- 884.4160
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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| DAVOL ELECTROSUGICAL PROBES (K915406) | Davol, Inc. | 1992-02-28 |
| SINGLE USE LAPARSCOPIC ELECTRODE (K904240) | Aspen Labs | 1991-02-19 |
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Recalls involving this device
No recalls on record reference this clearance.