510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913815Substantially Equivalent

Automated Biopsy Device, Modification

Hart Enterprises, Inc., Wyoming MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913815 is the FDA 510(k) clearance record for AUTOMATED BIOPSY DEVICE, MODIFICATION, a class I device, cleared for Hart Enterprises, Inc. on under FDA product code DWO (Needle, Biopsy, Cardiovascular). FDA records list 4 510(k) clearances for Hart Enterprises, Inc., from to . As of , FDA records show no recalls naming K913815.

Clearance record

Decision date
Received
(65 days to decision)
Product code
DWO Needle, Biopsy, Cardiovascular
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Hart Enterprises, Inc. 2131 Martindale SW, Wyoming MI
510(k) summary
Statement
Third party review
No

Clearances, product code DWO

Trailing 12 months

FDA records hold no clearances under product code DWO in the trailing twelve months.

FDA records show no clearances under product code DWO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260