# K991314: Coaguloop

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Jun 29, 1999 after 74 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: 2 generations back to K903323 (1990). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971512: Ams Coaguloop Resection Electrode, American Medical Systems, Inc. (1997) Summary page 2.
- K973820: Usa Elite System Vaportrode Vaporization Electrode and Vaportome Resection Electrode, Circon Corp. (1998) Summary page 2.

## Most influential descendants
- 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 resection, ablation, and fulguration in the prostate gland and the bladder.

Source page: https://510kreport.com/device/K991314
Methodology: https://510kreport.com/methodology