Edwards-Wallace Bourne Hall Catheter

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K910577 ↗

FDA Product Code

MFD

Device Class

Class II

Regulation

21 CFR Part 884.5250

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Mclaughlin Laparoscopic Grasper

  Class II

  FDA 510(k) K910578 Active Cleared 3 Apr 1991

• Marlow Suction/Irrigation Probes

  Class II

  FDA 510(k) K914872 Active Cleared 19 Nov 1991

• Pal (Probe for Aspiration and Lavage)

  Class II

  FDA 510(k) K911149 Active Cleared 5 Jul 1991

• Marlow/Reddick Laparoscopic Needle Holders

  Class II

  FDA 510(k) K913954 Active Cleared 18 Dec 1991

• Reich Suction/Irrigation Cannula

  Class II

  FDA 510(k) K911164 Active Cleared 5 Jul 1991

• Clarke Laparoscopic Ligator and Forceps

  Class II

  FDA 510(k) K903560 Active Cleared 6 Nov 1990

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