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510(k) K945124

BREAST LESION LOCALIZATION NEEDLE by Promex, Inc. — Product Code GDF

K945124 is an FDA 510(k) premarket notification submitted by Promex, Inc. for the device "BREAST LESION LOCALIZATION NEEDLE". The FDA issued a decision of Substantially Equivalent on November 22, 1994. The device falls under product code GDF (Guide, Needle, Surgical), a Class I device regulated under 21 CFR 878.4800. Promex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1994
Date Received
October 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Needle, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Promex, Inc.

  • K023450 — BIOPSY SITE TISSUE MARKER DEVICE (December 19, 2002)
  • K022634 — CO-AXIAL INTRODUCER NEEDLE (November 6, 2002)
  • K010400 — VACUUM ASSISTED CORE BIOPSY DEVICE (July 24, 2001)
  • K011270 — AUTOMATED CORE BIOPSY DEVICE (June 22, 2001)
  • K001132 — BONE BIOPSY NEEDLE (May 1, 2000)
  • K994272 — AUTOMATED CORE BIOPSY DEVICE (January 7, 2000)
  • K993435 — MANUAL BONE MARROW BIOPSY DEVICE (December 6, 1999)
  • K973184 — PROSTATE SEEDING NEEDLE (November 21, 1997)
  • K972865 — PROMEX ENT TISSUE REMOVAL SYSTEM (September 29, 1997)
  • K961078 — AUTOMATED VITRECTOMY DEVICE (June 14, 1996)

Other clearances for product code GDF

  • K031173 — NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 4001 (July 23, 2003)
  • K950311 — GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (May 26, 1995)
  • K950007 — SURGICAL INSTRUMENT GUIDE (March 15, 1995)
  • K944942 — BREAST LESION LOCALIZATION NEEDLE (November 4, 1994)
  • K935538 — BAUER TEMNO COAXIAL NEEDLE (February 22, 1994)
  • K935457 — LOCALIZATION WIRE OR MARKER - SURGICAL (February 17, 1994)
  • K923840 — NEEDLE-GRABBER (July 13, 1993)
  • K923835 — THE ELEVENTH FINGER (July 9, 1993)
  • K925875 — HORIZONTAL NEEDLE GUIDE ATTACHMENT (April 6, 1993)
  • K924270 — BREAST LESION LOCALIZATION NEEDLE (September 23, 1992)

FDA data resources