Cleared Traditional

K914608 - BREAST LES LOCAL WIRE ST. 48219/49220/4...

K914608 is the FDA 510(k) clearance for BREAST LES LOCAL WIRE ST. 48219/49220/4... by Dlp, Inc.. It is a Class 1 General & Plastic Surgery device (product code GAA) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K914608 · Dlp, Inc. · General & Plastic Surgery device
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Jan 1992
Decision
84d
Days
Class 1
Risk

K914608 is an FDA 510(k) clearance for the BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on January 9, 1992 after a review of 84 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 Dlp, Inc. devices

Submission Details

510(k) Number K914608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1991
Decision Date January 09, 1992
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
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 38
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K914608.
SYMBIOSIS BONE MARROW BIOPSY NEEDLE
K925416 · Symbiosis Corp. · Feb 1993
TURKEL THORACENTESIS SYSTEM
K922614 · Symbiosis Corp. · Jul 1992
KOPAN'S TARGET
K915417 · Medical Device Technologies, Inc. · Jan 1992
ASPIRATION/INJECTION NEEDLE
K913992 · Northgate Technologies, Inc. · Oct 1991
BONE MARROW BIOPSY TRAY
K912074 · Manan Medical Products, Inc. · Aug 1991
WILSON-COOK LUNG BIOPSY NEEDLE
K897050 · Wilson-Cook Medical, Inc. · Apr 1990