510(k) K913835

SNOWDEN-PENCER INSUFFLATOR TUBING SET by Snowden-Pencer — Product Code HIF

K913835 is an FDA 510(k) premarket notification submitted by Snowden-Pencer for the device "SNOWDEN-PENCER INSUFFLATOR TUBING SET". The FDA issued a decision of Substantially Equivalent on November 7, 1991. 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
November 7, 1991
Date Received
August 26, 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