Cleared Traditional

K935053 - BIVONA NASAL TURBINATE STENT

K935053 is an FDA 510(k) clearance for BIVONA NASAL TURBINATE STENT, manufactured by Bivona Medical Technologies. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K935053 · Bivona Medical Technologies · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
253d
Days
Class 1
Risk

K935053 is an FDA 510(k) clearance for the BIVONA NASAL TURBINATE STENT. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on July 1, 1994 after a review of 253 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4780 - 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.

FDA 510(k) Submission Details - K935053

510(k) Number K935053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1993
Decision Date July 01, 1994
Days to Decision 253 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 90d · This submission: 253d
Pathway characteristics
Predicate-based equivalence.

LYA Device Classification - Class 1, General Controls

Product Code LYA Splint, Intranasal Septal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4780
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 - LYA Splint, Intranasal Septal

All 45
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K935053.
C-FLEX SEPTAL SPLINTS
K952226 · Trebay Medical Corp. · Aug 1995
NASAL SEPTAL SPLINT
K952207 · Smith & Nephew Richards, Inc. · Jun 1995
NASAL SPLINT
K945555 · Ultracell Medical Technologies, Inc. · Jan 1995
MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT
K935658 · Merocel Corp. · Mar 1994
MEROCEL MEROSPLINT
K933152 · Merocel Corp. · Aug 1993
BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT
K925173 · Westmed Intl. · Jan 1993
K935053 · BIVONA NASAL TURBINATE STENT
Download PDF FDA Summary Bivona Medical Techno…