Cleared Traditional

K884631 - FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-8...

K884631 is the FDA 510(k) clearance for FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-8... by Xomed, Inc.. It is a Class 1 Ear, Nose, Throat device (product code LRC) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K884631 · Xomed, Inc. · Ear, Nose, Throat device
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Mar 1989
Decision
135d
Days
Class 1
Risk

K884631 is an FDA 510(k) clearance for the FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135). Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 22, 1989 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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 Xomed, Inc. devices

Submission Details

510(k) Number K884631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1988
Decision Date March 22, 1989
Days to Decision 135 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
46d slower than avg
Panel avg: 89d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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 - LRC Instrument, Ent Manual Surgical

All 49
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