# K012581: Reprocessed Stone Retrieval Baskets

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Feb 14, 2002 after 189 days
- Product code: FFL (Dislodger, Stone, Basket, Ureteral, Metal)
- Device class: 2
- Regulation: 21 CFR 876.4680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K871777 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970121: Stone Dislodger, Basket, Boston Scientific Corp (1997) Summary page 1.
- K951309: Stone Dislodger, Basket, Boston Scientific Corp (1995) Summary page 1.
- K935721: Stone Extractor, Boston Scientific Corp (1994). Our OCR of the scanned summary read K936721, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Boston Scientific Corporation’s Stone Dislodger Baskets”.
- K851965: Wilson-Cook Stone Extractor, Wilson-Cook Medical, Inc. (1985) Summary page 1.

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-0571-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th

## Indications for use
Reprocessed Stone Retrieval Baskets are used to entrap and remove renal stones and calculi via a rigid or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures.

Source page: https://510kreport.com/device/K012581
Methodology: https://510kreport.com/methodology