Rusch Latex Gold Foley Catheter— 510(k) K262056
Substantially EquivalentTeleflex Medical Sdn. Bhd.
FDA 510(k) clearance K262056 for Rusch Latex Gold Foley Catheter, Substantially Equivalent on 2026-08-05. Applicant: Teleflex Medical Sdn. Bhd.. Device class: 2.
Summary
Teleflex Medical's Rusch Latex Gold Foley Catheter is filed under product code EZL, balloon retention-type catheters. The record gives no sizes.
Class II, 21 CFR 876.5130. Gastroenterology and Urology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Teleflex filed from Kamunting, Malaysia. FDA found it substantially equivalent 48 calendar days after receipt (June 18 to August 5, 2026).
Clearance details
- Applicant
- Teleflex Medical Sdn. Bhd.
- Product code
- Product code EZL
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kamunting, MY
Recent devices under product code EZL
view allMore clearances from Teleflex Medical Sdn. Bhd.
view allAdverse events under product code EZL
product code EZL- Death
- 6
- Injury
- 796
- Malfunction
- 4,989
- Other
- 1
- Total
- 5,792
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.