510(k) K921963

DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 by Sun Medical, Inc. — Product Code HIF

K921963 is an FDA 510(k) premarket notification submitted by Sun Medical, Inc. for the device "DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900". The FDA issued a decision of Substantially Equivalent on September 11, 1992. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Sun Medical, Inc. has at least 3 other 510(k) clearances on record.