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Inclusice II Endoscope

by Sofamor Danek USA, Inc.

510(k) K946087

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK946087 Date21 Nov 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Inclusice II(Tm) Endoscope
510(k) Number
FDA Product Code
HRX
FDA applicant
Sofamor Danek USA,Inc.
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Inclusice II Endoscope is an endoscopic device used for medical procedures. It is designed to provide visualization and access during surgical interventions.

The device is supplied by Sofamor Danek USA, Inc. and has received FDA 510(k) clearance with product code HRX. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

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