Cleared Traditional

K955505 - OPTI-DRAIN MULTI-USE DRAINAGE CATHETER

K955505 is an FDA 510(k) clearance for OPTI-DRAIN MULTI-USE DRAINAGE CATHETER, manufactured by Navarre Biomedical , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K955505 · Navarre Biomedical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
68d
Days
Class 1
Risk

K955505 is an FDA 510(k) clearance for the OPTI-DRAIN MULTI-USE DRAINAGE CATHETER. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Navarre Biomedical , Ltd. (Plymouth, US). The FDA issued a Cleared decision on February 7, 1996 after a review of 68 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 Navarre Biomedical , Ltd. devices

FDA 510(k) Submission Details - K955505

510(k) Number K955505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1995
Decision Date February 07, 1996
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

Product Code GBX Catheter, Irrigation
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 - GBX Catheter, Irrigation

All 34
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K955505.
CLOSED FLUID COLLECTION SYSTEM
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K955339 · Northgate Technologies, Inc. · Mar 1996
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K926496 · Sil-Med Corp. · May 1995
DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER
K925243 · Deknatel, Inc. · Jul 1994
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K940352 · Storz Instrument Co. · Apr 1994