MEDLINE RED RUBBER URETHRAL CATHETER— 510(k) K092250
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K092250 for MEDLINE RED RUBBER URETHRAL CATHETER, Substantially Equivalent on 2010-01-21. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code EYB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mundelein, IL, US
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Recalls naming K092250
K-number listed on FDA's recall record- Z-2479-2026 — MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr; 9. DYND13522 - 22 Fr; 10. DYND13614 - 14 Fr; 11. DYND13616 - 16 Fr.
- Z-2492-2026 — MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DYNJ0040839
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092250.
Data sourced from openFDA. This site is unofficial and independent of the FDA.