510(k) · Cleared
ClearedDsnare Diminutive Polypectomy and Suction System, Model 00711087
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Endoscopy Group, Inc. · FCK Instrument, Biopsy, Suction
Cleared on May 30, 2006 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 30, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- FCK
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FCK? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All FCK devicesFCK Instrument, Biopsy, Suction: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCK
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · FCK
Too few FCK 510(k)s in any year since 2007 to give a median.
Recalls per year · FCK
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCK
1in 2025
MAUDE reports naming product code FCK, 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 | 1 | — | 1 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The dSnare Diminutive Polypectomy and Suction System is a non-diathermic polypectomy snare with a suction retention retrieval feature indicated for transendoscopic cold polypectomy and suction retrieval of lesions between 3mm and 7mm in size.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061201 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061201: Dsnare Diminutive Polypectomy and Suction System, Model 00711087.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061201
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026