Ophthalmic Sponges

• • Ongoing Z-1199-2023 FDA Class II ·initiated 20 Dec 2022

  Device packaging may contain open seals, compromising product sterility.

510(k) Number

K920354 ↗

FDA Product Code

HOZ

Device Class

Class II

Regulation

21 CFR Part 886.4790

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Anterior/Posterior Epistaxis Catheter

  Class I

  FDA 510(k) K945556 Active Cleared 18 Jan 1995

• Ultracell Nasal Packing

  Class I

  FDA 510(k) K920358 Active Cleared 30 Nov 1992

• Ultracell Instrument Wipe

  Class II

  FDA 510(k) K920353 Active Cleared 15 Sep 1992

• Nasal Splint

  Class I

  FDA 510(k) K945555 Active Cleared 19 Jan 1995

• Ultracell Suction Sponge

  Class II

  FDA 510(k) K972633 Active Cleared 17 Dec 1997

• Epistaxis Balloon Catheter with Packing

  Class I

  FDA 510(k) K945554 Active Cleared 17 Feb 1995

See all devices from Ultracell Medical Technologies, Inc. →