Cleared Traditional

K974311 - VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT

K974311 is the FDA 510(k) clearance for VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT by Gyrus Ent LLC. It is a Class 2 Ear, Nose, Throat device (product code KHJ) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K974311 · Gyrus Ent LLC · Ear, Nose, Throat device
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Mar 1998
Decision
107d
Days
Class 2
Risk

K974311 is an FDA 510(k) clearance for the VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT. Classified as Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (product code KHJ), Class II - Special Controls.

Submitted by Gyrus Ent LLC (Bartlett, US). The FDA issued a Cleared decision on March 4, 1998 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - 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 Gyrus Ent LLC devices

Submission Details

510(k) Number K974311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date March 04, 1998
Days to Decision 107 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 89d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHJ Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - KHJ Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)

All 9
Devices cleared under the same product code (KHJ) and FDA review panel - the closest regulatory comparables to K974311.
EPIFILM OTOLOGIC LAMINA
K982870 · Xomed, Inc. · Nov 1998
XOMED SILICONE PRE-FORM BLOCKS
K982294 · Xomed, Inc. · Sep 1998
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)
K972700 · Exmoor Plastics , Ltd. · Jul 1998
XOMED SILICONE BLOCK/STRIP
K970910 · Xomed, Inc. · May 1997
KARTUSH TM PATCHER
K964484 · Xomed, Inc. · Jan 1997
EXMOOR SILICONE RUBBER SHEET
K911503 · Exmoor Plastics , Ltd. · Nov 1991