Cleared Traditional

K973656 - DISPOSABLE SILICONE EPISTAXIS CATHETER

K973656 is an FDA 510(k) clearance for DISPOSABLE SILICONE EPISTAXIS CATHETER, manufactured by Specialty Surgical Products, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K973656 · Specialty Surgical Products, Inc. · Ear, Nose, Throat device
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Nov 1997
Decision
54d
Days
Class 1
Risk

K973656 is an FDA 510(k) clearance for the DISPOSABLE SILICONE EPISTAXIS CATHETER. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Specialty Surgical Products, Inc. (Hamilton, US). The FDA issued a Cleared decision on November 18, 1997 after a review of 54 days - a notably fast clearance 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: 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 Specialty Surgical Products, Inc. devices

FDA 510(k) Submission Details - K973656

510(k) Number K973656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1997
Decision Date November 18, 1997
Days to Decision 54 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 89d · This submission: 54d
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 13
Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K973656.
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K972076 · Boston Medical Products, Inc. · Jun 1997
EPI-STOP EPISTAXIS CATHETER
K972077 · Boston Medical Products, Inc. · Jun 1997