# K042877: Microverter Ureteral Access Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Percutaneous Systems, Inc.
- Decided: Nov 16, 2004 after 29 days
- Product code: KNY (Accessories, Catheter, G-U)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PSI SLIP Urology Introducer Sheath: named in the summary without a submission number
- (no number) Cook Flexor Ureteral Access Sheath: named in the summary without a submission number
- (no number) Boston Scientific Navigator Ureteral Access Sheath: named in the summary without a submission number

## Indications for use
The MICROVERTER Ureteral Access Sheath is intended to facilitate the introduction of endoscopes and other instruments into the urinary tract. The MICROVERTER Ureteral Access Sheath is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract, and as a lubricious barrier between the ureteral tissue and the endoscope or instrument.

Source page: https://510kreport.com/device/K042877
Methodology: https://510kreport.com/methodology