Catheter/Hemostatic/Geriatric

• • Ongoing Z-1050-2024 FDA Class I ·initiated 4 Dec 2023

  Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

510(k) Number

K780062 ↗

FDA Product Code

EZL

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Conform Stretch Bandage (5SIZES)

  Class I

  FDA 510(k) K771452 Active Cleared 12 Sep 1977

• Sponge, Curity Washed Gauze

  Class I

  FDA 510(k) K760094 Active Cleared 16 Jul 1976

• Micronet Light Dressing Sponge

  Class I

  FDA 510(k) K780408 Active Cleared 22 Mar 1978

• Urine Specimen Collecting Device

  Class II

  FDA 510(k) K772133 Active Cleared 28 Nov 1977

• T.E.D. Sequential Compression Sleeves

  Class II

  FDA 510(k) K781357 Active Cleared 20 Sep 1978

• Tender-Sorb Drain Sponges

  Class I

  FDA 510(k) K802225 Active Cleared 26 Sep 1980

See all devices from Kendall Research Center →