510(k) K890369

GALL STONE FORCEPS by Kinetic Medical Products — Product Code HTD

K890369 is an FDA 510(k) premarket notification submitted by Kinetic Medical Products for the device "GALL STONE FORCEPS". The FDA issued a decision of Substantially Equivalent on February 3, 1989. The device falls under product code HTD (Forceps), a Class I device regulated under 21 CFR 878.4800. Kinetic Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1989
Date Received
January 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type