Curity Premium Cystoscopy Tray

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

510(k) Number

K820850 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Curity Venous Catheterization Kit

  Class II

  FDA 510(k) K861828 Active Cleared 10 Jul 1986

• Curity Fiberoptic Intubating Airway

  Class I

  FDA 510(k) K855137 Active Cleared 11 Mar 1986

• Curity Curad Bandages

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  FDA 510(k) K810126 Active Cleared 6 Feb 1981

• The Kendall Urinary Output Monitor

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  FDA 510(k) K852083 Active Cleared 20 Sep 1985

• Kendall Curity Irrigation Syringe

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  FDA 510(k) K892436 Active Cleared 14 Jul 1989

• Curity Continuous Epidural Anesthesia Tray

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  FDA 510(k) K871066 Active Cleared 15 May 1987

See all devices from The Kendal Co. →

• What types of procedures is the Curity Premium Cystoscopy Tray specifically designed for, and how does it help during these procedures?

  The Curity Premium Cystoscopy Tray is designed exclusively for cystoscopy procedures, which involve examining the bladder and urethra using a cystoscope. It acts as a sterile, single-use surgical drape that creates a barrier to help maintain aseptic conditions in the operative field, thereby reducing the risk of contamination during the procedure.

• Is the Curity Premium Cystoscopy Tray reusable, or is it meant for single-use only? How does this affect its use in clinical settings?

  The Curity Premium Cystoscopy Tray is explicitly supplied as a sterile, single-use item. This design choice ensures that each procedure benefits from a fresh, uncontaminated barrier, minimizing infection risks and adhering to best practices for sterile field maintenance in clinical settings.

• What regulatory pathway was followed for the FDA clearance of this device, and what does the product code KKX indicate about its classification?

  The Curity Premium Cystoscopy Tray received FDA clearance through a 510(k) submission under the Substantially Equivalent (SESE) determination, meaning it was deemed comparable to a legally marketed device already on the market. The product code KKX classifies it as a Drape, Surgical, Antimicrobial, aligning with its intended use as a sterile barrier for cystoscopy procedures.

• How should the Curity Premium Cystoscopy Tray be stored, and are there any special handling instructions provided?

  While the provided data does not specify storage conditions beyond its sterile, single-use nature, standard practice for sterile surgical drapes typically requires protection from moisture, dust, and physical damage. It should be stored in its original packaging until use to preserve sterility and integrity.