Ultracell Instrument Wipe

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K920353 ↗

FDA Product Code

HEP

Device Class

Class II

Regulation

21 CFR Part 884.2660

Advisory Committee

Obstetrics/Gynecology

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

• 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

• 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. →

• Are these wipes intended for use in MRI environments, and if not, why not?

  No, these Ultracell Instrument Wipes are not intended for MRI environments. The product data does not mention MRI safety, and the lack of any MRI-related claims or certifications in the provided information confirms this. Since they are cellulose-based and not designed for imaging compatibility, they should not be used in MRI settings.

• How many wipes come in a single box, and what is the best way to store them for optimal use?

  Each box contains 20 wipes, measuring 3 inches by 3 inches with a thickness of 2 mm. Since these are non-sterile and reusable, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain their effectiveness for cleaning surgical instruments. Proper storage ensures they remain free of contamination until use.

• Can these wipes be used repeatedly, and if so, how should they be cleaned and maintained between uses?

  Yes, these wipes are designed for reuse. The product description explicitly states they are reusable for cleaning surgical instruments. While the data does not specify a cleaning protocol, standard practice for reusable cellulose wipes involves washing with mild detergent, rinsing thoroughly, and air-drying before reuse. Always follow facility-specific protocols to ensure proper sanitation and prevent cross-contamination.

• What are the dimensions of each wipe, and how does this size make them suitable for cleaning surgical instruments?

  Each wipe measures 3 inches by 3 inches with a thickness of 2 mm, providing a compact yet sturdy surface area. This size allows for targeted cleaning of small, precision surgical instruments while offering enough material to effectively remove debris and contaminants without excessive waste. The thickness also ensures durability during use.

• What is the regulatory pathway for this product, and how does it relate to its use in surgical settings?

  The Ultracell Instrument Wipe received FDA 510(k) clearance (K920353) under the classification of Class II medical devices, with a decision of *Substantially Equivalent* to a predicate device. This clearance confirms its compliance with U.S. regulatory standards for use in clinical settings like operating rooms and surgical suites. The advisory committee classification (Obstetrics/Gynecology) reflects the submission context, not a clinical limitation—these wipes can be used across surgical specialties for cleaning instruments.