510(k) · Cleared
Recalled · Class II · 2021Olympus SD Series Snares
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · FDI Snare, Flexible
Cleared on Mar 29, 1996 after a 108-day review. The FDA summary names its predicate without a number. 18 later devices descend from it. It has been recalled 5 times.
- Decided
- Mar 29, 1996
- Review
- 108 days
- Class
- Class II
- Product code
- FDI
- Recalls
- 5
- Predicates
- 0
18 later devices descend from it, 4 citing it directly.
- This deviceK955650 Olympus SD Series SnaresOlympus America, Inc. · 1996
- Descendant · cites it directly · 15 of its ownK131700 Sensation Short Throw, Captiflex, Captivator, Captivator II…Boston Scientific Corp · 2013 · Recalled
- Descendant · cites it directly · 10 of its ownK133987 Captivator II,Single-Use Polypectomy SnaresBoston Scientific Corporation · 2014 · Recalled
- Descendant · 2 generations on · 5 of its ownK172729 Polypectomy SnareHangzhou AGS MedTech Co., Ltd. · 2018
- Descendant · 2 generations on · 4 of its ownK160637 Rotatable SnaresBoston Scientific Corporation · 2016
- Descendant · 3 generations on · 3 of its ownK172758 Rotatable Snares, Non-Rotatable SnaresZhejiang Chuangxiang Medical Technology Co., Ltd. · 2018
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K131700Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use…Boston Scientific Corp · 2013 · cites it directly15descendants
- K133987Captivator II,Single-Use Polypectomy SnaresBoston Scientific Corporation · 2014 · cites it directly10descendants
- K172729Polypectomy SnareHangzhou AGS MedTech Co., Ltd. · 2018 · 2 generations on5descendants
- K160637Rotatable SnaresBoston Scientific Corporation · 2016 · 2 generations on4descendants
- K172758Rotatable Snares, Non-Rotatable SnaresZhejiang Chuangxiang Medical Technology Co., Ltd. · 2018 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955650 | Olympus SD Series Snares | Olympus America, Inc. | 1996 | — |
| +1 | 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 |
| +2 | K172729 | Polypectomy Snare | Hangzhou AGS MedTech Co., Ltd. | 2018 | — |
| +2 | K160637 | Rotatable Snares | Boston Scientific Corporation | 2016 | — |
| +3 | K172758 | Rotatable Snares, Non-Rotatable Snares | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | — | Olympus SD-1/2/3/4/5/6 pre-Amendment electrosurgical snares Named without a submission number | |
| * | — | Olympus SD-14/15 sterile disposable snares Named without a submission number |
What descends from it? (18)
See all 184 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 |
|---|---|---|---|---|
| Jan 4, 2021 | Class II | Z-0987-2021 | 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-0990-2021 | 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-0988-2021 | 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-0989-2021 | 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. |
| May 3, 2010 | Not classified | Z-2236-2010 | Other | An investigation of consumer complaints revealed the inability of the snare wire to be retracted into the snare tube after deployment of the snare. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K131700 (Boston Scientific Corp, 2013) has gone furthest, with 15 descendants of its own.
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 SD series of snares and the predicated shares are all designed to endoscopically resect tissue from within the Gl tract.
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/K955650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955650: Olympus SD Series Snares.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955650
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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