Cleared Traditional

K834540 - OP-CON SURGICAL INSTRUMENT #9

K834540 is an FDA 510(k) clearance for OP-CON SURGICAL INSTRUMENT #9, manufactured by Imm Enterprises , Ltd.. The device is a Class 1 Ear, Nose, Throat device with product code KBN cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K834540 · Imm Enterprises , Ltd. · Ear, Nose, Throat device
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Mar 1984
Decision
96d
Days
Class 1
Risk

K834540 is an FDA 510(k) clearance for the OP-CON SURGICAL INSTRUMENT #9. Classified as Gag, Mouth (product code KBN), Class I - General Controls.

Submitted by Imm Enterprises , Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 6, 1984 after a review of 96 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 Imm Enterprises , Ltd. devices

FDA 510(k) Submission Details - K834540

510(k) Number K834540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1983
Decision Date March 06, 1984
Days to Decision 96 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
6d slower than avg
Panel avg: 90d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

KBN Device Classification - Class 1, General Controls

Product Code KBN Gag, Mouth
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.