510(k) K915694

MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR by Medical Devices, Inc. — Product Code HIF

K915694 is an FDA 510(k) premarket notification submitted by Medical Devices, Inc. for the device "MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR". The FDA issued a decision of Substantially Equivalent on June 18, 1992. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Medical Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1992
Date Received
December 23, 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