510(k) · Cleared
ClearedFemrx Focused Monopolar (Fap) Operastar System [Outpatient Endoscopic Resection and Ablation (Opera)] [Specialized Tissu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynecare Innovation Center · KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Cleared on Mar 28, 1997 after a 142-day review. The FDA summary names its predicate without a number. 39 later devices descend from it.
- Decided
- Mar 28, 1997
- Review
- 142 days
- Class
- Class II
- Product code
- KNF
- Recalls
- None
- Predicates
- 0
39 later devices descend from it, 2 citing it directly.
- This deviceK964441 Femrx Focused Monopolar (Fap) Operastar System [Outpatient…Gynecare Innovation Center · 1997
- Descendant · cites it directly · 37 of its ownK031787 Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 34 of its ownK041774 Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004
- Descendant · 2 generations on · 25 of its ownK110038 Truclear Morcellator SystemSmith & Nephew, Inc. · 2011
- Descendant · 2 generations on · 25 of its ownK103389 Truclear Incisor Plus Blade 2.9Smith & Nephew, Inc. · 2011
- Descendant · 2 generations on · 24 of its ownK132015 Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc. · 2013 · Recalled
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K031787Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · cites it directly37descendants
- K041774Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004 · 2 generations on34descendants
- K110038Truclear Morcellator SystemSmith & Nephew, Inc. · 2011 · 2 generations on25descendants
- K103389Truclear Incisor Plus Blade 2.9Smith & Nephew, Inc. · 2011 · 2 generations on25descendants
- K132015Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc. · 2013 · 2 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964441 | Femrx Focused Monopolar (Fap) Operastar System [Outpatient Endoscopic… | Gynecare Innovation Center | 1997 | — |
| +1 | K031787 | Smith & Nephew Iur Morcellation System | Smith & Nephew, Inc. | 2003 | 1 |
| +2 | K041774 | Iur Reciprocating Morcellator Model # 7210517 | Smith & Nephew, Inc. | 2004 | — |
| +2 | K110038 | Truclear Morcellator System | Smith & Nephew, Inc. | 2011 | — |
| +2 | K103389 | Truclear Incisor Plus Blade 2.9 | Smith & Nephew, Inc. | 2011 | — |
| +2 | K132015 | Truclear Morcellation System and Truclear Morcellators | Smith & Nephew, Inc. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 4 | 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 KNF? 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 KNF device
- #1 K240503 Sonata Transcervical Fibroid Ablation System 2.2score 13.7 · 11 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 |
|---|---|---|---|
| * | — | STAR System resectoscope Named without a submission number |
What descends from it? (39)
See all 392 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?
- Of its descendants, K031787 (Smith & Nephew, Inc., 2003) has gone furthest, with 37 descendants of its own.
How does its category compare?
All KNF devicesKNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNF
Too few KNF 510(k)s in any year since 2007 to give a median.
Recalls per year · KNF
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNF
93in 2025
MAUDE reports naming product code KNF, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 3 | 1 |
| 2010 | 1 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 1 | — | 1 | 24 |
| 2014 | 1 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 1 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 1 | — | 0 | 93 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K964441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964441: Femrx Focused Monopolar (Fap) Operastar System [Outpatient Endoscopic Resection and Ablation (Opera)] [Specialized Tissu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964441
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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