Clarus (1100 +3 more) - 1100

• • Terminated Z-2405-2021 FDA Class II ·initiated 27 Jul 2021

  The sterile barrier seal may be compromised.

510(k) Number

K922881 ↗

FDA Product Code

GEX

Models / Variants

1100

1101

1102

1103 Laser Disc

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESK Substantially Equivalent — Kit

• Clarus Phoenix Neuro Endoscope Model 2160

  Class II

  FDA 510(k) K945296 Active Cleared 14 Jul 1995

• Clarus Murphypen Endoscope(2127-Xxx)

  Class II

  FDA 510(k) K962255 Active Cleared 11 Sep 1996

• Percscope Model 2600

  Class II

  FDA 510(k) K974579 Active Cleared 18 Feb 1998

• Clarus Series 2100 Endoscope

  Class II

  FDA 510(k) K923514 Active Cleared 7 Jan 1994

• Clarus Cholangiogram Catheter Kit

  Class I

  FDA 510(k) K925742 Active Cleared 1 Jun 1993

• Clarus Model 2127-900 Series Endoscope Adater (2127-900 Series)

  Class II

  FDA 510(k) K971584 Active Cleared 23 May 1997

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