# K971123: Stone Extractor

- Pathway: 510(k) (Traditional)
- Applicant: Phx Technologies Corp.
- Decided: Jun 27, 1997 after 92 days
- Product code: OCZ (Endoscopic Grasping/Cutting Instrument, Non-Powered)
- 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
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) Stone extractor: named in the summary without a submission number

## Indications for use
Indications: This instrument is indicated for use with a compatible trumpet valve during endoscopic surgery for facilitating the removal of galistones.

Source page: https://510kreport.com/device/K971123
Methodology: https://510kreport.com/methodology