Skip to content

Ams Coaguloop Resection Electrode

by American Medical Systems, Inc.

510(k) K971512

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK971512 Date24 Jul 1997ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FAS
Device class
Class II
Regulation
21 CFR Part 876.4300
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ams Coaguloop Resection Electrode is an active, urological electrosurgical device. It is intended for the resection, ablation, and fulguration of soft tissue.

This device is identified under FDA regulation number 876.4300 and was cleared via the 510(k) process under K971512. It is manufactured by American Medical Systems, Inc.

Other devices from American Medical Systems, Inc.

See all devices from American Medical Systems, Inc. →