510(k) K920986

SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700 by Snowden-Pencer — Product Code HIF

K920986 is an FDA 510(k) premarket notification submitted by Snowden-Pencer for the device "SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700". The FDA issued a decision of Substantially Equivalent on June 4, 1992. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Snowden-Pencer has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1992
Date Received
March 2, 1992
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