Rusch SoftSimplastic Foley Catheters
FDA 510(k) clearance K252537 · decided 2026-01-20
Clearance details
- K-number
- K252537
- Device name
- Rusch SoftSimplastic Foley Catheters
- Applicant
- Teleflex Medical Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-12
- Decision date
- 2026-01-20
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Kamunting, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.