510(k) K911913

PRECISION GLIDE - ENHANCED SURGICAL BLADE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GES

K911913 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "PRECISION GLIDE - ENHANCED SURGICAL BLADE". The FDA issued a decision of Substantially Equivalent on May 13, 1991. The device falls under product code GES (Blade, Scalpel), a Class I device regulated under 21 CFR 878.4800. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1991
Date Received
April 30, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blade, Scalpel
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type