Cleared Traditional

K002972 - MEROGEL CONTROL GEL ENT SURGICAL DRESSING (FDA 510(k) Clearance)

K002972 · Medtronic Xomed · Ear, Nose, Throat device
Dec 2000
Decision
84d
Days
Class 2
Risk

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

Submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on December 15, 2000, 84 days after receiving the submission on September 22, 2000.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3620.

Submission Details

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

Device Classification

Product Code KHJ - Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 874.3620