BREAST LESION LOCALIZATION NEEDLE— 510(k) K945124

Substantially Equivalent

Promex, Inc.

FDA 510(k) clearance K945124 for BREAST LESION LOCALIZATION NEEDLE, Substantially Equivalent on 1994-11-22. Applicant: Promex, Inc.. Device class: 1.

Clearance details

Applicant: Promex, Inc.
Product code: Code GDF
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1994-10-19
Decision date: 1994-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GDF

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K950007 — SURGICAL INSTRUMENT GUIDE1995-03-15
K944942 — BREAST LESION LOCALIZATION NEEDLE1994-11-04
K935538 — BAUER TEMNO COAXIAL NEEDLE1994-02-22

More clearances from Promex, Inc.

K023450 — BIOPSY SITE TISSUE MARKER DEVICE2002-12-19
K022634 — CO-AXIAL INTRODUCER NEEDLE2002-11-06
K010400 — VACUUM ASSISTED CORE BIOPSY DEVICE2001-07-24
K011270 — AUTOMATED CORE BIOPSY DEVICE2001-06-22
K001132 — BONE BIOPSY NEEDLE2000-05-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.