Medline Red Rubber Urethral Catheter
FDA 510(k) K092250 · Medline Industries, Inc.
510(k) numberK092250
Submission
- Device name
- Medline Red Rubber Urethral Catheter
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- July 28, 2009
- Decision date
- January 21, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EYB – Catheter, Ureteral, Gastro-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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| K083788 | Endo Optiks Urological Catheter for Endoscopy, Model SessrEYB · Traditional | Endooptiks, Inc. | 03/03/2009SE |
| K043581 | Dual Lumen CatheterEYB · Special | Acmi Corporation | 03/03/2005SE |
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Questions and answers
When was Medline Red Rubber Urethral Catheter cleared by the FDA?
Medline Red Rubber Urethral Catheter (K092250) received a 510(k) decision of Substantially Equivalent on January 21, 2010, 177 days after the submission was received.
What is the product code of K092250?
The FDA product code is EYB – Catheter, Ureteral, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.5130.