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Xomed Silicone Block/Strip

by Xomed, Inc. 510(k)

Active United States

510(k) K970910

Overview

The Xomed Silicone Block/Strip is a sterile implant made from silicone elastomer molded into square and/or rectangular shapes of various sizes, thicknesses, and durometer as specified on each product label. It is classified as a Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) under product code KHJ and is intended for use in Ear, Nose, Throat procedures.

The device is supplied sterile and is a single-use implant. It received FDA 510(k) clearance (K970910) on May 2, 1997, as substantially equivalent to predicate silicone sheeting products. The device is regulated as a Class II medical device with special controls and is manufactured by Xomed, Inc. in Jacksonville, Florida.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970910 Date2 May 1997ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KHJ
Device Class
Class II
Regulation
21 CFR Part 874.3620
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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