Cleared Traditional

K854327 - SUBCUTANEOUS TUNNELING NEEDLES & HANDLES

K854327 is an FDA 510(k) clearance for SUBCUTANEOUS TUNNELING NEEDLES & HANDLES, manufactured by Concord Laboratories, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GCB cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K854327 · Concord Laboratories, Inc. · General & Plastic Surgery device
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Nov 1985
Decision
16d
Days
Class 1
Risk

K854327 is an FDA 510(k) clearance for the SUBCUTANEOUS TUNNELING NEEDLES & HANDLES. Classified as Needle, Catheter (product code GCB), Class I - General Controls.

Submitted by Concord Laboratories, Inc. (Keene, US). The FDA issued a Cleared decision on November 13, 1985 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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 Concord Laboratories, Inc. devices

FDA 510(k) Submission Details - K854327

510(k) Number K854327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date November 13, 1985
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

GCB Device Classification - Class 1, General Controls

Product Code GCB Needle, Catheter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GCB Needle, Catheter

All 7
Devices cleared under the same product code (GCB) and FDA review panel - the closest regulatory comparables to K854327.
ADAIR/VERESS NEEDLE INTRODUCER SET
K930568 · Medical Dynamics, Inc. · Jul 1993
TURKEL PNEUMOTHORAX KIT
K923028 · Symbiosis Corp. · Aug 1992
ADAIR/VERESS NEEDLE INTRODUCER SET
K900374 · Medical Dynamics, Inc. · Apr 1990
MANAN EPIDURAL NEEDLE
K852428 · Manan Manufacturing Co., Inc. · Jun 1985
NEEDLES, DESIGN CHANGE, IV CATHETERS
K780896 · Jelco Laboratories · Aug 1978