Cleared Traditional

K801457 - ACCU-CORE DISPOSABLE BIOPSY NEEDLE

K801457 is the FDA 510(k) clearance for ACCU-CORE DISPOSABLE BIOPSY NEEDLE by Medline Industries, Inc.. It is a Class 1 General & Plastic Surgery device (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

Submission Details

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.

Device Classification

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 29
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K801457.
HYPODERMIC NEEDLES & SYRINGES
K821348 · Medi-Tech, Inc. · Jun 1982
CUATICO MYELOGRAPHY NEEDLES
K813367 · Dlp, Inc. · Jan 1982
DISPOSABLE CHIBA-TYPE NEEDLE
K813368 · Dlp, Inc. · Jan 1982
CULDOCENTESIS TRAY
K780624 · Cutter Laboratories, Inc. · May 1978
IOPSY TRAY FOR SOFT TISSUE BIOPSY
K771784 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1977