510(k) K811454

VANCE PROSTATIC ASPIRATION SET by Vance Products, Inc. — Product Code KNW

K811454 is an FDA 510(k) premarket notification submitted by Vance Products, Inc. for the device "VANCE PROSTATIC ASPIRATION SET". The FDA issued a decision of Substantially Equivalent on June 9, 1981. The device falls under product code KNW (Instrument, Biopsy), a Class II device regulated under 21 CFR 876.1075. Vance Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1981
Date Received
May 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type