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510(k) K981470

WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE by Worldwide Medical Technologies, LLC — Product Code IZH

K981470 is an FDA 510(k) premarket notification submitted by Worldwide Medical Technologies, LLC for the device "WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE". The FDA issued a decision of Substantially Equivalent on June 19, 1998. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Worldwide Medical Technologies, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1998
Date Received
April 23, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

Other clearances by Worldwide Medical Technologies, LLC

  • K062214 — BRACHYSCIENCES STRANDPORT (March 1, 2007)
  • K023179 — READI-STRAND, MODEL PSSTRAND (July 2, 2003)
  • K022705 — READI-STRAND, MODEL PSSTRAND (June 9, 2003)
  • K022389 — READI-LOAD SYSTEM, MODEL PSS 1820RL (May 6, 2003)
  • K020641 — SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 (October 29, 2002)
  • K020337 — READI-STRAND; MODEL PSSTRAND (July 29, 2002)
  • K020867 — BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL (May 20, 2002)
  • K991344 — WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS (November 5, 1999)
  • K981889 — WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE (July 31, 1998)
  • K982097 — WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD (June 25, 1998)

Other clearances for product code IZH

  • K203509 — SMART FINDER (July 14, 2021)
  • K202294 — Affirm Contrast Biopsy (October 5, 2020)
  • K191495 — Biopsy Positioner (July 3, 2019)
  • K161575 — Affirm Lateral Arm Upright Biopsy Accessory (August 10, 2016)
  • K161920 — Comfort Cover (July 15, 2016)
  • K153486 — Affirm Prone Biopsy System (April 1, 2016)
  • K152038 — MammoGRIP (December 22, 2015)
  • K123414 — SPECBOARD JR. (January 11, 2013)
  • K122836 — AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (January 11, 2013)
  • K113607 — BIOPSY DIGIT S BIOPSY SL (August 10, 2012)

FDA data resources