510(k) K112357
K112357 is an FDA 510(k) premarket notification submitted by Lexion Medical, LLC for the device "VESSEL GUARDIAN". The FDA issued a decision of Substantially Equivalent on November 10, 2011. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Lexion Medical, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2011
- Date Received
- August 16, 2011
- 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