510(k) K252537
K252537 is an FDA 510(k) premarket notification submitted by Teleflex Medical Sdn. Bhd. for the device "Rusch SoftSimplastic Foley Catheters". The FDA issued a decision of Substantially Equivalent on January 20, 2026. The device falls under product code EZL (Catheter, Retention Type, Balloon), a Class II device regulated under 21 CFR 876.5130. Teleflex Medical Sdn. Bhd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 2026
- Date Received
- August 12, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Retention Type, Balloon
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type