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Neuro Channel Endoscope Model 2232

by Clarus Medical Systems, Inc.

510(k) K945633

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK945633 Date19 Sep 1995ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0049-04 FDA Unclassified (pre-2012) initiated 15 Sep 2003

    Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GWG
Device Class
Class II
Regulation
21 CFR Part 882.1480
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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