510(k) K951326

BIOPSY DEVICE ACCESSORY by Biopsys Medical, Inc. — Product Code BTA

K951326 is an FDA 510(k) premarket notification submitted by Biopsys Medical, Inc. for the device "BIOPSY DEVICE ACCESSORY". The FDA issued a decision of Substantially Equivalent on May 15, 1995. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Biopsys Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1995
Date Received
March 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type