510(k) · Cleared
ClearedMill-Rose Disposable Polypectomy Snare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mill-Rose Laboratory · FDI Snare, Flexible
Cleared on May 23, 1997 as substantially equivalent to K912254 (Cox Medical Ent., Inc., 1991) and 2 other predicates after a 46-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- May 23, 1997
- Review
- 46 days
- Class
- Class II
- Product code
- FDI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K792343 (1979). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK792343 Diathermic Snare (Cresent Type)Mill-Rose Laboratory · 1979
- This deviceK971275 Mill-Rose Disposable Polypectomy SnareMill-Rose Laboratory · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K792343 | Diathermic Snare (Cresent Type) | Mill-Rose Laboratory | 1979 | — |
| 0 (this device) | K971275 | Mill-Rose Disposable Polypectomy Snare | Mill-Rose Laboratory | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 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 FDI? 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 FDI device
- #1 K251692 Advanced Tissue Resection Devicescore 10.9 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K912254 | Cox Diaposable Polypectomy SnareSummary page 1…Electrosurgical Unit) 5.) Common Name: Disposable Polypectomy Snare 6.) Proprietary Name: Mill-Rose Disposable Polypectomy Snare 7.) Substantially Equivalent Device: K912254 - Cox Medical Enterprises, Cox Disposable Polypectomy Snare K792343 - Mill-Rose Laboratories, Flexible Diathermic Snare K951600 -… | 1991 |
| * | K792343 | Diathermic Snare (Cresent Type)Summary page 1…e 6.) Proprietary Name: Mill-Rose Disposable Polypectomy Snare 7.) Substantially Equivalent Device: K912254 - Cox Medical Enterprises, Cox Disposable Polypectomy Snare K792343 - Mill-Rose Laboratories, Flexible Diathermic Snare K951600 - Mill-Rose Laboratories, Rotatable Polypectomy Snare 8.) Descriptio… | 1979 |
| * | K951600 | Mill-Rose Rotatable Polypectomy SnareSummary page 1…are 7.) Substantially Equivalent Device: K912254 - Cox Medical Enterprises, Cox Disposable Polypectomy Snare K792343 - Mill-Rose Laboratories, Flexible Diathermic Snare K951600 - Mill-Rose Laboratories, Rotatable Polypectomy Snare 8.) Description of Subject Device: The device consists of a handle, cable… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All FDI devicesFDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FDI
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FDI
247in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDI
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDI
274in 2025
MAUDE reports naming product code FDI, 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 | 48 |
| 2008 | 2 | — | 0 | 201 |
| 2009 | 1 | — | 0 | 265 |
| 2010 | 0 | — | 1 | 174 |
| 2011 | 1 | — | 0 | 177 |
| 2012 | 1 | — | 0 | 162 |
| 2013 | 3 | 87 | 0 | 191 |
| 2014 | 5 | 47 | 0 | 345 |
| 2015 | 3 | 62 | 1 | 195 |
| 2016 | 1 | — | 0 | 223 |
| 2017 | 1 | — | 0 | 154 |
| 2018 | 4 | 214 | 0 | 181 |
| 2019 | 3 | 100 | 0 | 135 |
| 2020 | 2 | — | 0 | 487 |
| 2021 | 1 | — | 0 | 211 |
| 2022 | 4 | 247 | 0 | 246 |
| 2023 | 1 | — | 0 | 209 |
| 2024 | 0 | — | 0 | 279 |
| 2025 | 0 | — | 2 | 274 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The intended use of this device is to electro surgically remove GIL tract -polyps - - -
through the channel of an endoscope.
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/K971275 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971275: Mill-Rose Disposable Polypectomy Snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971275
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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