510(k) K171139
K171139 is an FDA 510(k) premarket notification submitted by Buffalo Filter, LLC for the device "LaparoLight Veress Needle". The FDA issued a decision of Substantially Equivalent on May 18, 2017. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Buffalo Filter, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 2017
- Date Received
- Apr 18, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Insufflator, Laparoscopic
- Device Class
- Class II
- Regulation Number
- 884.1730
- Review Panel
- OB
- Submission Type
- 510(k)