510(k) K221995
K221995 is an FDA 510(k) premarket notification submitted by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. for the device "Gas Insufflator". The FDA issued a decision of Substantially Equivalent on March 28, 2023. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2023
- Date Received
- July 6, 2022
- 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