Cleared Traditional

K770959 - BOUGIE, FILIFORM, JACKSON (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K770959 · V. Mueller O.V. Baxter Healthcare Corp. · Ear, Nose, Throat device
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Jun 1977
Decision
18d
Days
Class 1
Risk

K770959 is an FDA 510(k) clearance for the BOUGIE, FILIFORM, JACKSON. Classified as Bougie, Eustachian (product code KBI), Class I - General Controls.

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1977 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4175 - 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 V. Mueller O.V. Baxter Healthcare Corp. devices

Submission Details

510(k) Number K770959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1977
Decision Date June 14, 1977
Days to Decision 18 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 89d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KBI Bougie, Eustachian
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4175
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.