Universa Percultaneous Drainage Catheter
FDA 510(k) K140085 · Cook Incorporated
510(k) numberK140085
Submission
- Device name
- Universa Percultaneous Drainage Catheter
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- January 13, 2014
- Decision date
- November 18, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FEW – Catheter, Malecot
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5090
- Specialty
- Gastroenterology, Urology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070879 | Bard Malecot and Pezzer DrainsFEW · Special | C.R. Bard, Inc. | 04/24/2007SE |
| K981258 | Manan Malecot Basket Drainage CatheterFEW · Traditional | Medical Device Technologies, Inc. | 04/22/1998SE |
| K954147 | Manan Malecot Basket Drainage CatheterFEW · Traditional | Manan Medical Products, Inc. | 03/26/1996SE |
| K954116 | Silicone Malecot Catheter with Pezzer/Mushroom TipFEW · Traditional | Technical Products, Inc. | 11/06/1995SE |
| K920423 | Olympic Smart Scale Care CenterFEW · Traditional | Olympic Medical Corp. | 06/11/1992SE |
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Questions and answers
When was Universa Percultaneous Drainage Catheter cleared by the FDA?
Universa Percultaneous Drainage Catheter (K140085) received a 510(k) decision of Substantially Equivalent on November 18, 2014, 309 days after the submission was received.
What is the product code of K140085?
The FDA product code is FEW – Catheter, Malecot, a Class II (moderate risk) device regulated under 21 CFR 876.5090.