510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951326Substantially Equivalent

Biopsy Device Accessory

Biopsys Medical, Inc., San Juan Capistrano CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951326 is the FDA 510(k) clearance record for BIOPSY DEVICE ACCESSORY, a class II device, cleared for Biopsys Medical, Inc. on under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)). FDA records list 15 510(k) clearances for Biopsys Medical, Inc., from to . As of , FDA records show no recalls naming K951326.

Clearance record

Decision date
Received
(53 days to decision)
Product code
BTA Pump, Portable, Aspiration (Manual Or Powered)
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Biopsys Medical, Inc. 27130 A Paseo Espada,, San Juan Capistrano CA
510(k) summary
Summary
Third party review
No

Clearances, product code BTA

Trailing 12 months
6 clearances under product code BTA in the twelve months to October 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code BTA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20264
June 20260
July 20260
August 20260
September 20260
October 20260