510(k) K934115

3000 ELECTRONIC INSUFFLATOR MODIFICATION by Cabot Medical Corp. — Product Code HIF

K934115 is an FDA 510(k) premarket notification submitted by Cabot Medical Corp. for the device "3000 ELECTRONIC INSUFFLATOR MODIFICATION". The FDA issued a decision of Substantially Equivalent on March 15, 1995. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Cabot Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1995
Date Received
August 24, 1993
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