Cleared Traditional

K002972 - MEROGEL CONTROL GEL ENT SURGICAL DRESSING

K002972 is an FDA 510(k) clearance for MEROGEL CONTROL GEL ENT SURGICAL DRESSING, manufactured by Medtronic Xomed. The device is a Class 2 Ear, Nose, Throat device with product code KHJ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K002972 · Medtronic Xomed · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
84d
Days
Class 2
Risk

K002972 is an FDA 510(k) clearance for the MEROGEL CONTROL GEL ENT SURGICAL DRESSING. Classified as Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) (product code KHJ), Class II - Special Controls.

Submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on December 15, 2000 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K002972

510(k) Number K002972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2000
Decision Date December 15, 2000
Days to Decision 84 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
6d faster than avg
Panel avg: 90d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHJ Device Classification - Class 2, Special Controls

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 33
Devices cleared under the same product code (KHJ) and FDA review panel - the closest regulatory comparables to K002972.
KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS
K033796 · Heinz Kurz GmbH Medizintechnik · Jan 2004
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
K013243 · Bioform, Inc. · Jan 2002
HYALOMATRIX CO
K003855 · Fidia Advanced Biopolymers Srl · Jul 2001
MEROGEL OTOLOGIC PACK
K001148 · Xomed, Inc. · Jun 2000
TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)
K991324 · Heinz Kurz · May 1999
EPIFILM OTOLOGIC LAMINA
K982870 · Xomed, Inc. · Nov 1998
K002972 · MEROGEL CONTROL GEL ENT SURGICAL DRESSING
Download PDF FDA Summary Medtronic Xomed