510(k) K172835

GRI-Alleset Veress Needle by Gri Medical and Electronic Technology Co., Ltd. — Product Code HIF

K172835 is an FDA 510(k) premarket notification submitted by Gri Medical and Electronic Technology Co., Ltd. for the device "GRI-Alleset Veress Needle". The FDA issued a decision of Substantially Equivalent on June 11, 2018. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Gri Medical and Electronic Technology Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2018
Date Received
September 19, 2017
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