4-SURE Female Catheter

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

510(k) Number

K931047 ↗

FDA Product Code

EZD

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• 4 Sure Tm Enema Bag Set

  Class I

  FDA 510(k) K922398 Active Cleared 17 Jun 1993

• 4-Sure Nelaton Catheter

  Class II

  FDA 510(k) K931048 Active Cleared 14 Feb 1994

• 4 Sure Tm Feeding Tubes

  Class II

  FDA 510(k) K921853 Active Cleared 13 Jul 1993

• 4 Sure Tm Anesthesia Extension Set

  Class II

  FDA 510(k) K924995 Active Cleared 30 Dec 1992

• 4 Sure Tm Rectal Tube

  Class I

  FDA 510(k) K921852 Active Cleared 8 Oct 1993

• 4 Sure Tm Nasal Oxygen Cannula

  Class I

  FDA 510(k) K922397 Active Cleared 18 Mar 1993

See all devices from Boston Pacific Medical, Inc. →

• What clinical settings is the 4-Sure Female Catheter designed for use in?

  The 4-Sure Female Catheter is specifically designed for urinary drainage in female patients within controlled clinical environments. This includes hospitals, urology clinics, and outpatient care settings where proper aseptic techniques are maintained to ensure patient safety and infection control.

• Is the 4-Sure Female Catheter reusable or intended for single-use only?

  The 4-Sure Female Catheter is explicitly labeled as a single-use device. It is supplied sterile in packaging, meaning it must be discarded after one use to maintain sterility and prevent cross-contamination.

• How do I know if the catheter is radiopaque, and why does that matter?

  Yes, the 4-Sure Female Catheter is radiopaque, meaning it is visible under X-ray imaging. This feature is critical for clinicians because it allows for real-time verification of proper placement within the urethra during procedures, reducing the risk of misplacement or complications.

• What storage conditions should I follow for the 4-Sure Female Catheter?

  While the provided data does not specify exact storage conditions, the catheter is supplied in sterile packaging, so it should be stored in a clean, dry environment protected from contamination. Always follow standard medical device storage protocols to preserve sterility until use.

• What does the FDA 510(k) clearance (K931047) under the Gastroenterology and Urology advisory committees mean for this device?

  The FDA 510(k) clearance (K931047) indicates that the 4-Sure Female Catheter has been determined to be substantially equivalent to a legally marketed predicate device. This means the FDA reviewed it under the Gastroenterology and Urology advisory committees and found it to meet safety and effectiveness standards for urinary drainage in female patients, but it does not imply approval for any specific clinical indication—only that it complies with regulatory requirements for its intended use.