510(k) K262056
K262056 is an FDA 510(k) premarket notification submitted by Teleflex Medical Sdn. Bhd. for the device "Rusch Latex Gold Foley Catheter". The FDA issued a decision of Substantially Equivalent on August 5, 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 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 2026
- Date Received
- June 18, 2026
- 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