InsufflatOR Needle
FDA 510(k) clearance K142700 · decided 2014-12-19
Clearance details
- K-number
- K142700
- Device name
- InsufflatOR Needle
- Applicant
- Gynetech Pty. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-09-22
- Decision date
- 2014-12-19
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- HIF
- Device class
- 2
- Regulation number
- 884.1730
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Thomastown, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.