510(k) · Cleared
ClearedDeuce Polypectomy Snare, Models 000995, 000996,000997, 000998
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Endoscopic Technologies, Inc. · FDI Snare, Flexible
Cleared on Jul 22, 2009 as substantially equivalent to K081580 (Conmed Corporation, 2008) and 3 other predicates after a 75-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Jul 22, 2009
- Review
- 75 days
- Class
- Class II
- Product code
- FDI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K894762 (1989). 12 ancestors in all, the oldest K820430 (1982). No later device cites it as a predicate yet.
- Root · 4 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
- 3 generations backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
- 2 generations backK013348 Modification to: Erbe Apc Connector Hose and Probes, Models…Erbe USA, Inc. · 2001
- 1 generation backK081580 Beamer Argon Snare ProbeConmed Corporation · 2008
- This deviceK091355 Deuce Polypectomy Snare, Models 000995, 000996,000997, 000998Conmed Endoscopic Technologies, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894762 | B100 Disposable Handpiece | Beacon Laboratories, Inc. | 1989 | — |
| −3 | K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator… | Erbe USA, Inc. | 1996 | — |
| −2 | K013348 | Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158… | Erbe USA, Inc. | 2001 | — |
| −1 | K081580 | Beamer Argon Snare Probe | Conmed Corporation | 2008 | — |
| 0 (this device) | K091355 | Deuce Polypectomy Snare, Models 000995, 000996,000997, 000998 | Conmed Endoscopic Technologies, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 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? (4)
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 |
|---|---|---|---|
| * | K081580 | Beamer Argon Snare ProbeSummary page 1…evice Name: ConMed Deuce Polypectomy Snare 3.. Identification of Predicate or Legally Marketed Device: ConMed BeamerTm Snare Probe cleared under K081580 on June 20, 2008 Cook SonnetTM Polypectomy Snare cleared under K050294 on March 31, 2005 Medi-Glo… | 2008 |
| * | K050294 | Cook Ireland Sonnet Polypectomy SnareSummary page 1…cate or Legally Marketed Device: ConMed BeamerTm Snare Probe cleared under K081580 on June 20, 2008 Cook SonnetTM Polypectomy Snare cleared under K050294 on March 31, 2005 Medi-Globe Polypectomy Snare cleared under K943935 on May 26,1995 Polypectomy Snares cl… | 2005 |
| * | K943935 | Gip/Medi-Globe Polypectomy SnaresSummary page 1…81580 on June 20, 2008 Cook SonnetTM Polypectomy Snare cleared under K050294 on March 31, 2005 Medi-Globe Polypectomy Snare cleared under K943935 on May 26,1995 Polypectomy Snares cleared under K820430 on April 8, 1982 4. Device Description: The ConMed D… | 1995 |
| * | K820430 | Diathermic SnaresSummary page 1…Snare cleared under K050294 on March 31, 2005 Medi-Globe Polypectomy Snare cleared under K943935 on May 26,1995 Polypectomy Snares cleared under K820430 on April 8, 1982 4. Device Description: The ConMed Deuce Polypectomy Snare is a sterile, single patient use,… | 1982 |
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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 2 of the 12 ancestors have a recall of any class.
How does its category compare?
All FDI devicesFDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
May be used in conjunction with an electrosurgical generator for endoscopic resection of a polypoid lesion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091355: Deuce Polypectomy Snare, Models 000995, 000996,000997, 000998.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091355
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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