Infyna Chic Urethral Catheter

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

Full name

Infyna Chic

510(k) Number

K191633 ↗

FDA product code

GBM

Device class

Class II

Regulation

21 CFR Part 876.5130

Advisory committee

Gastroenterology, Urology

FDA decision

SESE Substantially Equivalent

Manufacturer's product page: Infyna Chic™ Catheters

• Hollister

  Class I

  CE/MDR

• Hollister

  Class I

  CE/MDR

• Hollister

  Class I

  CE/MDR

• Hollister

  Class I

  CE/MDR

• Hollister

  Class I

  CE/MDR

• Hollister

  Class I

  CE/MDR

See all devices from Hollister Incorporated →

• What clinical settings is the Infyna Chic urethral catheter intended for use in?

  The Infyna Chic is designed for temporary or intermittent urinary drainage in adult patients and is intended for use in clinical environments such as hospitals, outpatient care centers, and home healthcare settings. Its versatility aligns with both urological and gastroenterological procedures, ensuring compatibility with a range of patient care scenarios.

• Is the Infyna Chic catheter reusable or single-use, and how should it be stored?

  The Infyna Chic is supplied as a single-use, sterile product. To maintain sterility and functionality, it must be stored according to the manufacturer’s instructions, which likely include keeping it in its original packaging, away from direct sunlight or extreme temperatures, and ensuring the packaging remains unopened until use.

• What sizes or models of the Infyna Chic are available, and how can I identify them?

  The Infyna Chic is available in multiple sizes, each corresponding to a unique reference code (e.g., 1000317571, 3008806809, etc.). These codes are listed in the OpenFDA database under the device’s registration. The specific size or model can be matched to patient needs based on clinical guidelines, with the manufacturer’s packaging or documentation typically indicating the correct code for each catheter.

• Does the Infyna Chic require any special handling or preparation before use?

  Since the Infyna Chic is a sterile, single-use device, it should be handled using aseptic techniques to prevent contamination. Before use, verify the packaging is intact and unopened, and follow the manufacturer’s instructions for proper insertion and drainage setup. No additional preparation (e.g., sterilization) is required, as it is pre-sterilized for clinical use.

• What regulatory pathways does the Infyna Chic follow, and how does that affect its use?

  The Infyna Chic complies with FDA 510(k) and MDR (Medical Device Regulation) standards, confirming its safety and performance for temporary urinary drainage. The device was granted Substantially Equivalent (SE) clearance under the FDA’s 510(k) process, meaning it meets the regulatory requirements for Class II medical devices. Clinicians can rely on its compliance with these pathways for trusted use in urological and gastroenterological procedures.