Microverter Ureteral Access Sheath
FDA 510(k) K042877 · Percutaneous Systems, Inc.
510(k) numberK042877
Submission
- Device name
- Microverter Ureteral Access Sheath
- Applicant
- Percutaneous Systems, Inc.
Mountain View, CA, US - Received
- October 18, 2004
- Decision date
- November 16, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNY – Accessories, Catheter, G-U
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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| K131803 | Guardian Urethral SheathKNY · Special | Solace Therapeutics | 08/20/2013SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K102887 | Accordion Stone Management Device Model AC281205 and AC3814510FFL · Traditional | 05/16/2011SE |
| K090485 | Coaxial Accordion Ercp Device, Models C0AC19001, COAC20005, COAC22003LQR · Traditional | 07/22/2009SE |
| K082803 | Coaxial Accordion Stone Management Device, Model: COAC12005 - COA20015FFL · Traditional | 11/13/2008SE |
| K061766 | Expressway Intermittent CatheterEZD · Traditional | 03/09/2007SE |
| K052298 | Cystoglide Introducer SheathKNY · Traditional | 12/12/2006SE |
| K052134 | Cystoglide Dilating Introducer SheathKNY · Traditional | 09/22/2005SE |
| K052048 | AccordionFFL · Traditional | 09/13/2005SE |
| K042531 | Updated Slip Urology Introducer SheathKNY · Special | 02/01/2005SE |
| K040520 | Slip Urology Introducer SheathKNY · Traditional | 05/20/2004SE |
| K040519 | Slip Urology CatheterEZD · Traditional | 05/20/2004SE |
Questions and answers
When was Microverter Ureteral Access Sheath cleared by the FDA?
Microverter Ureteral Access Sheath (K042877) received a 510(k) decision of Substantially Equivalent on November 16, 2004, 29 days after the submission was received.
What is the product code of K042877?
The FDA product code is KNY – Accessories, Catheter, G-U, a Class II (moderate risk) device regulated under 21 CFR 876.5130.