Wallace Oocyte Retrieval Set-16g, Model MEONS1633; Wallace Oocyte Retrieval Set-17g, Model MEONS1733

• • Terminated Z-0593-2009 FDA Unclassified (pre-2012) ·initiated 23 Oct 2008

  Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.

510(k) Number

K000628 ↗

FDA Product Code

MQE

Models / Variants

Wallace Oocyte Retrieval Set-16g, Model MEONS1633

Wallace Oocyte Retrieval Set-17g, Model MEONS1733

FDA applicant

Sims Portex , Ltd.

Device Class

Class II

Regulation

21 CFR Part 884.6100

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Csecure Combined Spinal/Epidural Anesthesia System with Lock

  Class II

  FDA 510(k) K993619 Active Cleared 28 Apr 2000

• Sims Portex Epidural Catheter, 20g Model# 4910-16/17; 21g Model# 4910-18

  Class II

  FDA 510(k) K992471 Active Cleared 22 Oct 1999

• Spinal Anesthesia Needles and Introducer Needles

  Class II

  FDA 510(k) K983858 Active Cleared 29 Jan 1999

• Sims Portex Anesthesia Catheter

  Class II

  FDA 510(k) K994275 Active Cleared 22 Feb 2000

• Cpap System, Model 102001

  Class II

  FDA 510(k) K001318 Active Cleared 20 Jul 2000

• Electrostatic Hydrophobic Breathing Filter

  Class II

  FDA 510(k) K002201 Active Cleared 5 Feb 2001

See all devices from Sims Portex, Inc. →