Cleared Traditional

STERILE, DISPOSABLE NEEDLE (K852817) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K852817 · Fabersanitas, S.A. · General & Plastic Surgery device
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Jul 1985
Decision
25d
Days
Class 1
Risk

K852817 is an FDA 510(k) clearance for the STERILE, DISPOSABLE NEEDLE. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Fabersanitas, S.A. (15-50004 Zaragoza-Spain, ES). The FDA issued a Cleared decision on July 26, 1985 after a review of 25 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 Fabersanitas, S.A. devices

Submission Details

510(k) Number K852817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1985
Decision Date July 26, 1985
Days to Decision 25 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
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 10
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K852817.
MONOJECT BONE MARROW BIOPSY TRAYS
K945109 · Sherwood Medical Co. · Nov 1994
WILSON-COOK LUNG BIOPSY NEEDLE
K897050 · Wilson-Cook Medical, Inc. · Apr 1990
MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED
K883014 · Sherwood Medical Co. · Jul 1988
HAWKIN NEEDLE
K851953 · Wilson-Cook Medical, Inc. · May 1985
CHIBA NEEDLE
K851957 · Wilson-Cook Medical, Inc. · May 1985
TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709
K831392 · Travenol Laboratories, S.A. · Jul 1983