510(k) K942207

REFLEX INS INSUFFLATION NEEDLE by Richard-Allan Medical — Product Code HIF

K942207 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical for the device "REFLEX INS INSUFFLATION NEEDLE". The FDA issued a decision of Substantially Equivalent on May 27, 1994. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Richard-Allan Medical has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1994
Date Received
May 5, 1994
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