Convatec · Class II · Cleared Jul 1, 2025
| K-number | K250699 |
| Device name | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) |
| Applicant | Convatec |
| Product code | EZD |
| Device class | Class II |
| Decision date | Jul 1, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.5130 |
The Cure Twist Female Catheter is a pre-lubricated, sterile, single-use intermittent urinary catheter designed for female bladder drainage. It is inserted through the urethra and comes in multiple sizes (CH8 to CH16), packaged in a plastic case with a twist cap for discreet portability. The device may be used in healthcare facilities, homes, workplaces, and public settings.
The device features a straight tip, latex-free polyvinyl chloride (PVC) construction, smooth tip with polished eyelets, and water-based pre-lubrication. It is an open-end system without a collection bag and is sterilized by ethylene oxide. The primary difference from the predicate is the packaging: the subject device uses a plastic case with twist cap designed for discreet pocketing, whereas the predicate uses standard sterile packaging.
Sterilization validation per AAMI/ISO 11135-1:2014/AMD 1:2018 and ISO 10993-7:2008/AMD:2019; biocompatibility testing per ISO 10993-1:2018; sterile packaging per ISO 11607-1:2019 and ISO 11607-2:2019; shelf-life testing per ISO 11607-1:2006; packaging integrity per ASTM F2096-11 (2019); and dimensional and performance testing per ISO 20696:2018.
The subject device has identical indications for use, materials, design features (straight tip, smooth tip, polished eyelets, pre-lubrication), and functional characteristics as the predicate Cure Ultra (K221593), differing only in primary packaging design. The packaging change is cosmetic and does not affect the safety or performance of the catheter itself. Performance testing demonstrates equivalent biocompatibility, sterilization, shelf-life stability, and mechanical properties to the predicate.
View the full FDA submission: accessdata.fda.gov