510(k) K912044

MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR by Multigon Industries, Inc. — Product Code HIF

K912044 is an FDA 510(k) premarket notification submitted by Multigon Industries, Inc. for the device "MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR". The FDA issued a decision of Substantially Equivalent on June 24, 1991. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Multigon Industries, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1991
Date Received
May 8, 1991
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