510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011270Substantially Equivalent

Automated Core Biopsy Device

Promex, Inc., Franklin IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011270 is the FDA 510(k) clearance record for AUTOMATED CORE BIOPSY DEVICE, a class II device, cleared for Promex, Inc. on under FDA product code FCG (Biopsy Needle). FDA records list 18 510(k) clearances for Promex, Inc., from to . As of , FDA records show no recalls naming K011270.

Clearance record

Decision date
Received
(57 days to decision)
Product code
FCG Biopsy Needle
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Promex, Inc. 3049 Hudson St., Franklin IN
510(k) summary
Statement
Third party review
No

Clearances, product code FCG

Trailing 12 months

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

FDA records show no clearances under product code FCG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCG, 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