Cleared Traditional

K854238 - NEEDLE W/STYLET FOR IMPLANTATION

K854238 is an FDA 510(k) clearance for NEEDLE W/STYLET FOR IMPLANTATION, manufactured by Microvasive. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K854238 · Microvasive · General & Plastic Surgery device
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Nov 1985
Decision
23d
Days
Class 1
Risk

K854238 is an FDA 510(k) clearance for the NEEDLE W/STYLET FOR IMPLANTATION. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Microvasive (Milford, US). The FDA issued a Cleared decision on November 13, 1985 after a review of 23 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 Microvasive devices

FDA 510(k) Submission Details - K854238

510(k) Number K854238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1985
Decision Date November 13, 1985
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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 K854238.
MANAN BREST TUMOR LOCALIZATION NEEDLE
K863848 · Manan Manufacturing Co., Inc. · Oct 1986
TBI NEEDLE
K860582 · Hobbs Medical, Inc. · Mar 1986
ANGIOMED FINE NEEDLES AND NEEDLE SET
K855141 · Angiomed U.S., Inc. · Jan 1986
MANAN TROCAR STYLE BIOPSY NEEDLE
K852426 · Manan Manufacturing Co., Inc. · Jun 1985
MANAN SPINAL NEEDLE
K852427 · Manan Manufacturing Co., Inc. · Jun 1985
HAWKIN NEEDLE
K851953 · Wilson-Cook Medical, Inc. · May 1985