Cleared Traditional

K801457 - ACCU-CORE DISPOSABLE BIOPSY NEEDLE

K801457 is an FDA 510(k) clearance for ACCU-CORE DISPOSABLE BIOPSY NEEDLE, manufactured by Medline Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K801457 · Medline Industries, Inc. · General & Plastic Surgery device
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Jul 1980
Decision
20d
Days
Class 1
Risk

K801457 is an FDA 510(k) clearance for the ACCU-CORE DISPOSABLE BIOPSY NEEDLE. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980 after a review of 20 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.

View all Medline Industries, Inc. devices

FDA 510(k) Submission Details - K801457

510(k) Number K801457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1980
Decision Date July 14, 1980
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

Product Code GAA Needle, Aspiration And Injection, Disposable
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 - GAA Needle, Aspiration And Injection, Disposable

All 72
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K801457.
PHERESIS NEEDLE ASSEMBLY
K810076 · Haemonetics Corp. · Mar 1981
ADT BONE MARROW BIOPSY-ASPIR. NEELDE
K801753 · A.D.T. Lab Industries · Aug 1980
ADT BONE MARROW ASPIRATION NEEDLE
K801754 · A.D.T. Lab Industries · Aug 1980
ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE
K800408 · A.D.T. Lab Industries · Apr 1980
ADT BONE MARROW BIOPSY ASPIRATION TRAY
K800409 · A.D.T. Lab Industries · Apr 1980
ADT BONE MARROW BIOPSY-ASPIRATION TRAY
K800410 · A.D.T. Lab Industries · Apr 1980