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510(k) K981889

WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE by Worldwide Medical Technologies, LLC — Product Code FCG

K981889 is an FDA 510(k) premarket notification submitted by Worldwide Medical Technologies, LLC for the device "WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE". The FDA issued a decision of Substantially Equivalent on July 31, 1998. The device falls under product code FCG (Biopsy Needle), a Class II device regulated under 21 CFR 876.1075. Worldwide Medical Technologies, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1998
Date Received
May 29, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
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)
  • K982097 — WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD (June 25, 1998)
  • K981470 — WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE (June 19, 1998)

Other clearances for product code FCG

  • K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (October 24, 2025)
  • K250994 — ClearTip FNA and FNB Types (August 21, 2025)
  • K241209 — EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) (July 29, 2024)
  • K231422 — Precision GI (August 28, 2023)
  • K231267 — ClearTip (June 30, 2023)
  • K230909 — EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (May 30, 2023)
  • K212423 — EndoDrill® Model X (March 29, 2023)
  • K212819 — Disposable Biopsy Refill Needle (July 6, 2022)
  • K212822 — Disposable Coaxial Biopsy Needle (July 6, 2022)
  • K210476 — EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy (May 20, 2021)

FDA data resources