510(k) K931056

DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING by American Cyanamid Co. — Product Code GDW

K931056 is an FDA 510(k) premarket notification submitted by American Cyanamid Co. for the device "DAVIS+GECK VALTRAC BIOFRAG ANASTOMOSIS RING". The FDA issued a decision of Substantially Equivalent on July 8, 1993. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. American Cyanamid Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1993
Date Received
March 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
Review Panel
SU
Submission Type