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510(k) K980137

WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY by Worldwide Medical Technologies, LLC — Product Code LRO

K980137 is an FDA 510(k) premarket notification submitted by Worldwide Medical Technologies, LLC for the device "WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY". The FDA issued a decision of Substantially Equivalent on January 30, 1998. The device falls under product code LRO (General Surgery Tray), a Class II device regulated under 21 CFR 878.4370. Worldwide Medical Technologies, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1998
Date Received
January 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
General Surgery Tray
Device Class
Class II
Regulation Number
878.4370
Review Panel
SU
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

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 LRO

  • K213481 — Medline General Surgery Tray (May 24, 2022)
  • K212258 — Medline Cardiovascular Procedure Kit (December 3, 2021)
  • K041080 — SURGICAL DRAPE KIT - D.I.R.R.A. SRL (November 30, 2004)
  • K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (March 31, 2003)
  • K023276 — AMSINO TRACHEOSTOMY CARE TRAY (December 9, 2002)
  • K971061 — OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (June 11, 1997)
  • K971062 — OPPORTUNITY INC. GENERAL PURPOSE TRAY (June 9, 1997)
  • K932221 — NEUROLOGICAL OR CRANI TRAYS (PACKS) (March 19, 1997)
  • K970286 — PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (March 10, 1997)
  • K965201 — O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE (February 14, 1997)

FDA data resources