Cleared Traditional

K891537 - CORE BIOPSY NEEDLE, CATALOG CODE #54006

K891537 is an FDA 510(k) clearance for CORE BIOPSY NEEDLE, manufactured by Dlp, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDM cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K891537 · Dlp, Inc. · General & Plastic Surgery device
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Apr 1989
Decision
32d
Days
Class 1
Risk

K891537 is an FDA 510(k) clearance for the CORE BIOPSY NEEDLE, CATALOG CODE #54006. Classified as Needle, Aspiration And Injection, Reusable (product code GDM), Class I - General Controls.

Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on April 18, 1989 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K891537

510(k) Number K891537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1989
Decision Date April 18, 1989
Days to Decision 32 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

GDM Device Classification - Class 1, General Controls

Product Code GDM Needle, Aspiration And Injection, Reusable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GDM Needle, Aspiration And Injection, Reusable

All 47
Devices cleared under the same product code (GDM) and FDA review panel - the closest regulatory comparables to K891537.
ROCKET BONE MARROW NEEDLE
K895551 · A & A Medical, Inc. · Oct 1989
SINGLE LUMEN O'NEIL ASPIRATION & IRRIGATION NEEDLE
K895594 · Go Medical Industries Pty. , Ltd. · Oct 1989
ADG BONE BIOPSY SYSTEM
K890722 · American Design Group, Inc. · Sep 1989
ASPIRATING AND IRRIGATING CYSTS NEEDLES
K885283 · Go Medical Industries Pty. , Ltd. · Mar 1989
KLEIN HANDLE
K881783 · E.L. Medico Intl., Inc. · Dec 1988
KLEIN NEEDLE
K881784 · E.L. Medico Intl., Inc. · Dec 1988
K891537 · CORE BIOPSY NEEDLE, CATALOG CODE #54006
Download PDF Dlp, Inc.