510(k) K162582
K162582 is an FDA 510(k) premarket notification submitted by Fisher & Paykel Healthcare for the device "HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit". The FDA issued a decision of Substantially Equivalent on Jun 23, 2017. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Fisher & Paykel Healthcare has 74 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 23, 2017
- Date Received
- Sep 15, 2016
- 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
- 510(k)