Cleared Traditional

BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL

K020867 · Worldwide Medical Technologies, LLC · Gastroenterology & Urology
May 2002
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K020867 is an FDA 510(k) clearance for the BONE MARROW ASPIRATION NEEDLE, MODEL BMB1110J, BONE MARROW HARVEST NEEDLE, MODEL BMHN1104VX, & BONE MARROW BIOPSY NEEDL, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Worldwide Medical Technologies, LLC (Woodbury, US). The FDA issued a Cleared decision on May 20, 2002, 63 days after receiving the submission on March 18, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K020867 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2002
Decision Date May 20, 2002
Days to Decision 63 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KNW — Instrument, Biopsy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1075

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