# K082735: Stone Grasping Basket, Model PD-T1 2115

- Pathway: 510(k) (Traditional)
- Applicant: Sialo Technology, Ltd.
- Decided: Mar 13, 2009 after 176 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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: 4 generations back to K926166 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012527: Ksea Sialoendoscopes and Accessories, KARL STORZ Endoscopy-America, Inc. (2001)
- K051073: Midiview Series of Microendoscopes, Millennium Devices, Inc. (2006)
- K902944: Wittich Nitinol Stone Basket, Cook, Inc. (1990) Summary page 1.

## Indications for use
The Stone Grasping Basket is a medical device indicated for use by qualified surgeons in the treatment of salivary gland diseases. It is used endoscopically to entrap and remove mobile stones and stone fragments smaller than 5mm from the salivary gland.

Source page: https://510kreport.com/device/K082735
Methodology: https://510kreport.com/methodology