Safestretch Incontinence System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K851681 ↗

FDA Product Code

KNX

FDA applicant

Dbt Medical , Ltd.

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Safeseal Reusable Urinal System

  Class I

  FDA 510(k) K851682 Active Cleared 24 Jun 1985

• Ostomy Bags Ileostomy

  Class I

  FDA 510(k) K851680 Active Cleared 27 Jun 1985

• Ostomy Bags Colostomy

  Class I

  FDA 510(k) K851679 Active Cleared 27 Jun 1985

• Ostomy Bags Uretherostomy

  Class I

  FDA 510(k) K851678 Active Cleared 27 Jun 1985

• What is the Safestretch Incontinence System used for?

  The Safestretch Incontinence System is designed as an accessory for indwelling catheters to manage urinary incontinence. It provides a secure, stretch-resistant connection between the catheter and drainage bag, minimizing the risk of dislodgement or leakage. This helps maintain reliable urinary drainage in both hospital and home care environments.

• How is the Safestretch Incontinence System supplied and prepared for use?

  The system is supplied sterile and ready for immediate clinical use. No additional preparation is required before connecting it to an indwelling catheter and drainage bag. This ensures convenience and reduces the risk of contamination prior to use.

• Is the Safestretch Incontinence System intended for single-use or reuse?

  The Safestretch Incontinence System is explicitly designed for single-use only. This design choice aligns with clinical best practices for infection control and patient safety, particularly in managing urinary incontinence where sterility is critical.

• What regulatory approval does the Safestretch Incontinence System hold?

  The Safestretch Incontinence System holds FDA 510(k) clearance under the classification of collectors for urine and associated accessories for indwelling catheters. This clearance confirms compliance with U.S. medical device regulations and substantiates its equivalence to predicate devices in this category.

• Are there different sizes or configurations available for the Safestretch Incontinence System?

  The system is standardized to ensure compatibility with common indwelling catheter drainage systems. While specific sizes or configurations are not detailed in the provided data, the design is intended to fit standard clinical setups, ensuring ease of integration into existing urinary management protocols.