# K972091: Ams Foreign Body Extrator

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Aug 29, 1997 after 86 days
- Product code: FFL (Dislodger, Stone, Basket, Ureteral, Metal)
- Device class: 2
- Regulation: 21 CFR 876.4680
- 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) Richard Wolf 8393 Modular Biopsy Forceps: named in the summary without a submission number
- (no number) Richard Wolf series 8962 Rigid Forceps with Alligator Jaws: named in the summary without a submission number

## Indications for use
The AMS Foreign Body Extractor is intended for use in the removal of a foreign body from the bladder under direct vision.

Source page: https://510kreport.com/device/K972091
Methodology: https://510kreport.com/methodology