510(k) · Cleared
ClearedEndoRotor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interscope, Inc. · PTE Endoscopic Morcellator Gastroenterology
Cleared on Apr 18, 2017 as substantially equivalent to K142029 (Hologic, Inc., 2014) after a 95-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Apr 18, 2017
- Review
- 95 days
- Class
- Class II
- Product code
- PTE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K953695 (1995). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK953695 Dyonics Disposable Arthroscopic BladesSmith & Nephew Dyonics, Inc. · 1995
- 4 generations backK031787 Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK041774 Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc. · 2004
- 2 generations backK132015 Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc. · 2013 · Recalled
- 1 generation backK142029 Myosure Hysteroscopic Tissue Removal SystemHologic, Inc. · 2014
- This deviceK170120 EndoRotorInterscope, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK181127 EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap…Interscope, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K181127EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set…Interscope, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K953695 | Dyonics Disposable Arthroscopic Blades | Smith & Nephew Dyonics, Inc. | 1995 | — |
| −4 | K031787 | Smith & Nephew Iur Morcellation System | Smith & Nephew, Inc. | 2003 | 1 |
| −3 | K041774 | Iur Reciprocating Morcellator Model # 7210517 | Smith & Nephew, Inc. | 2004 | — |
| −2 | K132015 | Truclear Morcellation System and Truclear Morcellators | Smith & Nephew, Inc. | 2013 | 1 |
| −1 | K142029 | Myosure Hysteroscopic Tissue Removal System | Hologic, Inc. | 2014 | — |
| 0 (this device) | K170120 | EndoRotor | Interscope, Inc. | 2017 | — |
| +1 | K181127 | EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor… | Interscope, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 PTE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K142029 | Myosure Hysteroscopic Tissue Removal SystemSummary page 4…anufacturer: Hologic, Inc. Proprietary Name: MyoSure Hysteroscopic Tissue Removal System 510(k) Number: K142029 Classification Name: Hysteroscope and accessories Classification Regulation: 21 CFR 884.1690 Pr… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181127 | EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set… | 2019 | 0 |
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 22 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K181127 (Interscope, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K142029.
How does its category compare?
All PTE devicesPTE Endoscopic Morcellator Gastroenterology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PTE
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · PTE
Too few PTE 510(k)s in any year since 2007 to give a median.
Recalls per year · PTE
No recall names PTE since 2007.
Adverse event reports per year · PTE
1in 2023
MAUDE reports naming product code PTE, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EndoRotor is intended for use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection).
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/K170120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170120: EndoRotor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170120
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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