510(k) · Cleared
Recalled · Class II · 2025Single Use Electrosurgical Snare SD-400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · FDI Snare, Flexible
Cleared on Dec 7, 2017 as substantially equivalent to K133987 (Boston Scientific Corporation, 2014) after an 87-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it. It has been recalled 41 times.
- Decided
- Dec 7, 2017
- Review
- 87 days
- Class
- Class II
- Product code
- FDI
- Recalls
- 41
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950496 (1995). 6 ancestors in all, the oldest K941750 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK950496 Snare, Flexible, Electrosurgical Cutting & Coagulation Device &…Boston Scientific Corp · 1995
- 3 generations backK992477 RotosnareInscope, LLC · 1999
- 2 generations backK131700 Sensation Short Throw, Captiflex, Captivator, Captivator II…Boston Scientific Corp · 2013 · Recalled
- 1 generation backK133987 Captivator II,Single-Use Polypectomy SnaresBoston Scientific Corporation · 2014 · Recalled
- This deviceK172734 Single Use Electrosurgical Snare SD-400Olympus Medical Systems Corp. · 2017
- Descendant · cites it directly · 1 of its ownK173673 AcuSnare Polypectomy SnareWilson-Cook Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK220089 Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK191048 AcuSnare Polypectomy Snare - DuckbillWilson-Cook Medical, Inc. · 2019
Most influential descendants
Showing 3 of 3 · See all- K173673AcuSnare Polypectomy SnareWilson-Cook Medical, Inc. · 2018 · cites it directly1descendant
- K220089Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co., Ltd. · 2022 · cites it directly0descendants
- K191048AcuSnare Polypectomy Snare - DuckbillWilson-Cook Medical, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950496 | Snare, Flexible, Electrosurgical Cutting & Coagulation Device & Accessories | Boston Scientific Corp | 1995 | — |
| −3 | K992477 | Rotosnare | Inscope, LLC | 1999 | — |
| −2 | K131700 | Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile… | Boston Scientific Corp | 2013 | 8 |
| −1 | K133987 | Captivator II,Single-Use Polypectomy Snares | Boston Scientific Corporation | 2014 | 1 |
| 0 (this device) | K172734 | Single Use Electrosurgical Snare SD-400 | Olympus Medical Systems Corp. | 2017 | — |
| +1 | K173673 | AcuSnare Polypectomy Snare | Wilson-Cook Medical, Inc. | 2018 | — |
| +1 | K220089 | Disposable Polyp Snare | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022 | — |
| +2 | K191048 | AcuSnare Polypectomy Snare - Duckbill | Wilson-Cook Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K133987 | Captivator II,Single-Use Polypectomy SnaresSummary page 5…cate Device Device name Applicant 510(k)# CAPTIVATOR II,SINGLE-USE Boston Scientific Corporation K133987 POLYPECTOMY SNARES IV. Device Description The subject device is designed to be used with an Olympus endoscope for the removal an… | 2014 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2025 | Class II | Z-0483-2026 | Packaging | Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton. |
| Oct 6, 2025 | Class II | Z-0482-2026 | Packaging | Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton. |
| Jan 4, 2021 | Class II | Z-0991-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0993-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0994-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0996-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0997-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1000-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1002-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1004-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1005-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1006-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1010-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1017-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1023-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1025-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0992-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0995-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1001-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1007-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1008-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1009-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1012-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1014-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1018-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1026-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1027-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1028-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1029-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1003-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1011-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1015-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1016-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1019-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1020-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1022-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0998-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0999-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1013-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1021-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-1024-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
The 5 latest of 41 recalls; the web page lists all.
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 4.4 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K173673 (Wilson-Cook Medical, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K133987.
How does its category compare?
All FDI devicesFDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · FDI
1in 2023
2007high 5 (2014) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · FDI
247in 2022
2007high 247 (2022) · low 47 (2014)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDI
2in 2025
2007high 2 (2025) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDI
274in 2025
2007high 487 (2020) · low 48 (2007)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?
These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172734: Single Use Electrosurgical Snare SD-400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172734
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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