510(k) K142700
K142700 is an FDA 510(k) premarket notification submitted by Gynetech Pty. , Ltd. for the device "InsufflatOR Needle". The FDA issued a decision of Substantially Equivalent on December 19, 2014. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Gynetech Pty. , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2014
- Date Received
- September 22, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Laparoscopic
- Device Class
- Class II
- Regulation Number
- 884.1730
- Review Panel
- OB
- Submission Type