510(k) K242772
K242772 is an FDA 510(k) premarket notification submitted by SmartsurgN, Inc. for the device "AirSurgN Insufflator (10030/AirSurgN)". The FDA issued a decision of Substantially Equivalent on April 11, 2025. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. SmartsurgN, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2025
- Date Received
- September 13, 2024
- 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