510(k) · Cleared
ClearedCoaguloop
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 Jun 29, 1999 as substantially equivalent to K971512 (American Medical Systems, Inc., 1997) and 1 other predicate after a 74-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it.
- Decided
- Jun 29, 1999
- Review
- 74 days
- Class
- Class II
- Product code
- FAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K903323 (1990). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK903323 Resectoscope LoopsOlympus Corp. · 1990
- 1 generation backK971512 Ams Coaguloop Resection ElectrodeAmerican Medical Systems, Inc. · 1997
- This deviceK991314 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903323 | Resectoscope Loops | Olympus Corp. | 1990 | — |
| −1 | K971512 | Ams Coaguloop Resection Electrode | American Medical Systems, Inc. | 1997 | — |
| 0 (this device) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K971512 | Ams Coaguloop Resection ElectrodeSummary page 2…ctoscope electrodes that are in commercial distribution. The predicate devices that AMS is claiming substantial equivalence to are the AMS Coaguloop™ Resection Electrode K971512 and the Circon/ACMI Vaportome™ Resection Loop Electrode K973820. STERILIZATION METHODOLOGY Sterilization is based on the recomm… | 1997 |
| * | K973820 | Usa Elite System Vaportrode Vaporization Electrode and Vaportome Resection ElectrodeSummary page 2…dicate devices that AMS is claiming substantial equivalence to are the AMS Coaguloop™ Resection Electrode K971512 and the Circon/ACMI Vaportome™ Resection Loop Electrode K973820. STERILIZATION METHODOLOGY Sterilization is based on the recommendations in ANSI/AAMI and ISO 11137 Guideline for the Steriliza… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050910 | Roei Working Element and Roel Cutting Loops | 2005 | 1 |
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K050910 (Roei Medical Technologies, Ltd., 2005) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K971512.
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 resection, ablation,
and fulguration in the prostate gland and the bladder.
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/K991314 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991314: Coaguloop.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991314
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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