# K161110: ClearPetra Suction-Evacuation Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Co., Ltd.
- Decided: Oct 12, 2016 after 175 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K770378 (1977). 24 ancestors in all.
7 later devices descend from it; 6 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151084: Well Lead Ureteral Access Sheath, Well Lead Medical Co., Ltd. (2016) Summary page 4.
- K150158: Schoelly Cystoscopes/Hysteroscopes and Accessories, Schoelly Fiberoptic GmbH (2015) Summary page 4.
- K151308: Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set, Schoelly Fiberoptic GmbH (2016) Summary page 4.

## Most influential descendants
- K243820: Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 (2025), 1 descendant of its own
- K261915: Navigator™ Flex Ureteral Access Sheath Set (2026), 0 descendants of its own
- K252572: Prodeon Urethral Sheath System (2025), 0 descendants of its own
- K250128: Single Use Suction-Evacuation Ureteral Access Sheath (2025), 0 descendants of its own
- K243025: Ureteral Access Sheath (2025), 0 descendants of its own

## Indications for use
The ClearPetra Suction-Evacuation Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.

Source page: https://510kreport.com/device/K161110
Methodology: https://510kreport.com/methodology