510(k) · Cleared
ClearedAms Coaguloop Resection Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems, Inc. · FAS Electrode, Electrosurgical, Active, Urological
Cleared on Jul 24, 1997 as substantially equivalent to K903323 (Olympus Corp., 1990) after an 87-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it.
- Decided
- Jul 24, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- FAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903323 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK903323 Resectoscope LoopsOlympus Corp. · 1990
- This deviceK971512 Ams Coaguloop Resection ElectrodeAmerican Medical Systems, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK991314 CoaguloopAmerican Medical Systems, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK050910 Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd. · 2005
- Descendant · 2 generations on · 0 of its ownK053322 Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd. · 2006
Most influential descendants
Showing 3 of 3 · See all- K991314CoaguloopAmerican Medical Systems, Inc. · 1999 · cites it directly2descendants
- K050910Roei Working Element and Roel Cutting LoopsRoei Medical Technologies, Ltd. · 2005 · cites it directly1descendant
- K053322Modification to: Roei Working Element and Roei Cutting LoopsRoei Medical Technologies, Ltd. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903323 | Resectoscope Loops | Olympus Corp. | 1990 | — |
| 0 (this device) | K971512 | Ams Coaguloop Resection Electrode | American Medical Systems, Inc. | 1997 | — |
| +1 | K991314 | Coaguloop | American Medical Systems, Inc. | 1999 | — |
| +1 | K050910 | Roei Working Element and Roel Cutting Loops | Roei Medical Technologies, Ltd. | 2005 | — |
| +2 | K053322 | Modification to: Roei Working Element and Roei Cutting Loops | Roei Medical Technologies, Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FAS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FAS device
- #1 K250522 Multi4 Systemscore 11.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K903323 | Resectoscope LoopsSummary page 1…ctrosurgical, Endoscopic (With or Without Accessories) Device Trade Name: AMS Coaguloop™ Resection Electrode IV. PREDICATE DEVICE Olympus™ Resectoscope Loop Electrode K903323 V. DEVICE DESCRIPTION The Coaguloop™ consists of either a single or double conductor. The conductor(s) either form or are in el… | 1990 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FAS devicesFAS Electrode, Electrosurgical, Active, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAS
150in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAS
395in 2025
MAUDE reports naming product code FAS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 3 | 150 | 0 | 25 |
| 2011 | 1 | — | 0 | 33 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 48 |
| 2014 | 0 | — | 0 | 52 |
| 2015 | 1 | — | 0 | 82 |
| 2016 | 1 | — | 2 | 69 |
| 2017 | 2 | — | 0 | 121 |
| 2018 | 0 | — | 0 | 70 |
| 2019 | 0 | — | 0 | 61 |
| 2020 | 0 | — | 0 | 100 |
| 2021 | 2 | — | 4 | 102 |
| 2022 | 1 | — | 0 | 147 |
| 2023 | 0 | — | 1 | 329 |
| 2024 | 1 | — | 0 | 310 |
| 2025 | 2 | — | 0 | 395 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AMS Coaguloop™ Resection Electrode is intended to be used for the resection, ablation,
and fulguration in the prostate gland.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971512: Ams Coaguloop Resection Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971512
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026