Cleared Traditional

K900583 - MODIFIED BIVONA EPISTAXIS CATHETER

K900583 is an FDA 510(k) clearance for MODIFIED BIVONA EPISTAXIS CATHETER, manufactured by Bivona Medical Technologies. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K900583 · Bivona Medical Technologies · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
183d
Days
Class 1
Risk

K900583 is an FDA 510(k) clearance for the MODIFIED BIVONA EPISTAXIS CATHETER. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on August 9, 1990 after a review of 183 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4100 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Bivona Medical Technologies devices

FDA 510(k) Submission Details - K900583

510(k) Number K900583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1990
Decision Date August 09, 1990
Days to Decision 183 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 90d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

EMX Device Classification - Class 1, General Controls

Product Code EMX Balloon, Epistaxis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4100
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 - EMX Balloon, Epistaxis

All 18
Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K900583.
NASAL-SINUS PACKING
K924542 · Ultracell Medical Technologies, Inc. · Feb 1993
ULTRACELL NASAL PACKING
K920358 · Ultracell Medical Technologies, Inc. · Nov 1992
EPISTAXIS NASAL BALLOON CATHETER
K921199 · Smith & Nephew Richards, Inc. · Jul 1992
FOX POST NASAL BALLOON CATHETER
K841040 · Inmed Corp. · Aug 1984
EPISTAXIS CATHETER/KIT
K821584 · Bivona Medical Technologies · Jun 1982
GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM.
K811496 · Narco Scientific · Jun 1981