Ultracell Suction Sponge

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K972633 ↗

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

• Ophthalmic Sponges Open recall

  Class II

  FDA 510(k) K920354 Active Cleared 5 Aug 1992

• Epistaxis Balloon Catheter with Packing

  Class I

  FDA 510(k) K945554 Active Cleared 17 Feb 1995

See all devices from Ultracell Medical Technologies, Inc. →

• What is the Ultracell Suction Sponge primarily used for in surgical settings?

  The Ultracell Suction Sponge is designed specifically for ophthalmic surgeries, where it serves as a protective barrier for delicate eye tissues. It absorbs excess fluids and acts as a filter during aspiration, helping to maintain clarity and dryness in the surgical field.

• Is the Ultracell Suction Sponge intended for single-use or can it be reused?

  The Ultracell Suction Sponge is explicitly supplied as a single-use device. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and device integrity.

• How should the Ultracell Suction Sponge be stored before use?

  The device must be stored properly to ensure its integrity before use. Since it is supplied non-sterile, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures until sterilized by the facility’s standard protocols prior to surgical use.

• What regulatory pathway was followed for the FDA clearance of the Ultracell Suction Sponge?

  The Ultracell Suction Sponge received FDA clearance through a 510(k) submission, classified as a Class II medical device under the Ophthalmic category (product code HOZ). The clearance was granted on December 17, 1997, with the determination of substantial equivalence to a predicate device.