Cleared Traditional

K811496 - GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM.

K811496 is an FDA 510(k) clearance for GOTTSCHALK NASOSTAT SLIM LINE, manufactured by Narco Scientific. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K811496 · Narco Scientific · Ear, Nose, Throat device
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Jun 1981
Decision
20d
Days
Class 1
Risk

K811496 is an FDA 510(k) clearance for the GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM.. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Narco Scientific (Mchenry, US). The FDA issued a Cleared decision on June 16, 1981 after a review of 20 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 Narco Scientific devices

FDA 510(k) Submission Details - K811496

510(k) Number K811496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1981
Decision Date June 16, 1981
Days to Decision 20 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
70d faster than avg
Panel avg: 90d · This submission: 20d
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.