Cleared Traditional

K890926 - SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE

K890926 is an FDA 510(k) clearance for SURECUT BMB BONE MARROW BIOPSY/ASPIRATI..., manufactured by Meadox Surgimed, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K890926 · Meadox Surgimed, Inc. · General Hospital
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Jun 1989
Decision
116d
Days
Class 2
Risk

K890926 is an FDA 510(k) clearance for the SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Meadox Surgimed, Inc. (Oakland, US). The FDA issued a Cleared decision on June 20, 1989 after a review of 116 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Meadox Surgimed, Inc. devices

FDA 510(k) Submission Details - K890926

510(k) Number K890926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1989
Decision Date June 20, 1989
Days to Decision 116 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 129d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 473
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K890926.
EXEL HUBER NEEDLE
K895769 · Exel Intl. · Feb 1990
EXEL SPINAL NEEDLES
K895771 · Exel Intl. · Feb 1990
B-D PEND NEEDLE
K895630 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES
K884211 · Marquette Medical, Inc. · Oct 1988
WINGED NON-CORING NEEDLE SET
K884212 · Marquette Medical, Inc. · Oct 1988
NON-CORING NEEDLES
K883009 · Quinton, Inc. · Oct 1988