Cleared Traditional

K933600 - NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE...

K933600 is an FDA 510(k) clearance for NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE..., 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 244-day FDA review.

K933600 · Navarre Biomedical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
244d
Days
Class 1
Risk

K933600 is an FDA 510(k) clearance for the NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Navarre Biomedical , Ltd. (Hamel, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 244 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Navarre Biomedical , Ltd. devices

FDA 510(k) Submission Details - K933600

510(k) Number K933600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1993
Decision Date March 28, 1994
Days to Decision 244 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
129d slower than avg
Panel avg: 115d · This submission: 244d
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 K933600.
SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN
K926496 · Sil-Med Corp. · May 1995
DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER
K925243 · Deknatel, Inc. · Jul 1994
STORZ N5941 SERIES MEDICAL GRADE TUBING
K940352 · Storz Instrument Co. · Apr 1994
SIL-SLIP FLAT SUCTION DRAIN
K926408 · Sil-Med Corp. · Feb 1994
SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE
K926495 · Sil-Med Corp. · Feb 1994
ERCP CATHETER, HYDROPHILIC COATED
K932205 · Wilson-Cook Medical, Inc. · Jan 1994