510(k) K854568

V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP by American V. Mueller — Product Code GEF

K854568 is an FDA 510(k) premarket notification submitted by American V. Mueller for the device "V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP". The FDA issued a decision of Substantially Equivalent on December 2, 1985. The device falls under product code GEF (Applier, Staple, Surgical,), a Class I device regulated under 21 CFR 878.4800. American V. Mueller has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1985
Date Received
November 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applier, Staple, Surgical,
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type