Rusch Mmg/O'neil Catheter

• • Ongoing Z-0227-2023 FDA Class II ·initiated 20 Sep 2022 ·on shared 510(k) K010420

  Product may not be sterile

• • Terminated Z-0771-2017 FDA Class II ·initiated 22 Nov 2016 ·on shared 510(k) K010420

  Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.

• • Terminated Z-1083-05 FDA Unclassified (pre-2012) ·initiated 11 Jul 2005

  There is a lack of assurance of sterility for parts of these lots of product.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K010420 ↗

FDA Product Code

FCM

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Rusch Safety Clear Uncuffed with Magill Tip

  Class II

  FDA 510(k) K925507 Active Cleared 2 Sep 1993

• Rusch Agt Pvc Pref Oral Trach Tube, Uncuf W/Mur Ey Open recall

  Class II

  FDA 510(k) K931166 Active Cleared 22 Jun 1993

• Rusch Tracheal Bronchial Y Stent

  Class II

  FDA 510(k) K953593 Active Cleared 13 Oct 1995

• Rusch Agt Pvc Pref Nasal Trach Tub/Uncuf W/Mur Eye Open recall

  Class II

  FDA 510(k) K931165 Active Cleared 22 Jun 1993

• Rusch Lasertubus/Rusch Laser Resistant Cuffed with Murphy Eye

  Class II

  FDA 510(k) K935842 Active Cleared 23 May 1995

• Rusch Simplastic Foley Catheterization Set

  Class II

  FDA 510(k) K963993 Active Cleared 17 Dec 1996

See all devices from Rusch, Inc. →