Cleared Traditional

K884631 - FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)

K884631 is an FDA 510(k) clearance for FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-8..., manufactured by Xomed, Inc.. The device is a Class 1 Ear, Nose, Throat device with 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

FDA 510(k) Submission Details - K884631

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
45d slower than avg
Panel avg: 90d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

LRC Device Classification - Class 1, General Controls

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 62
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