# K971512: Ams Coaguloop Resection Electrode

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Jul 24, 1997 after 87 days
- Product code: FAS (Electrode, Electrosurgical, Active, Urological)
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903323 (1990). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903323: Resectoscope Loops, Olympus Corp. (1990) Summary page 1.

## Most influential descendants
- K991314: Coaguloop (1999), 2 descendants of its own
- K050910: Roei Working Element and Roel Cutting Loops (2005), 1 descendant of its own
- K053322: Modification to: Roei Working Element and Roei Cutting Loops (2006), 0 descendants of its own

## Indications for use
The AMS Coaguloop™ Resection Electrode is intended to be used for the resection, ablation, and fulguration in the prostate gland.

Source page: https://510kreport.com/device/K971512
Methodology: https://510kreport.com/methodology