510(k) · Cleared
ClearedGip/Medi-Globe Polypectomy Snares
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Globe Corp. · FDI Snare, Flexible
Cleared on May 26, 1995 after a 287-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- May 26, 1995
- Review
- 287 days
- Class
- Class II
- Product code
- FDI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK943935 Gip/Medi-Globe Polypectomy SnaresMedi-Globe Corp. · 1995
- Descendant · cites it directly · 0 of its ownK150316 Polypectomy SnareMicro-Tech (Nanjing) Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK103155 Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK091355 Deuce Polypectomy Snare, Models 000995, 000996,000997, 000998Conmed Endoscopic Technologies, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K150316Polypectomy SnareMicro-Tech (Nanjing) Co., Ltd. · 2015 · cites it directly0descendants
- K103155Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc. · 2011 · cites it directly0descendants
- K091355Deuce Polypectomy Snare, Models 000995, 000996,000997, 000998Conmed Endoscopic Technologies, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943935 | Gip/Medi-Globe Polypectomy Snares | Medi-Globe Corp. | 1995 | — |
| +1 | K150316 | Polypectomy Snare | Micro-Tech (Nanjing) Co., Ltd. | 2015 | — |
| +1 | K103155 | Sumo Access and Tissue Resection System | Apollo Endosurgery, Inc. | 2011 | — |
| +1 | K091355 | Deuce Polypectomy Snare, Models 000995, 000996,000997, 000998 | Conmed Endoscopic Technologies, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K150316 (Micro-Tech (Nanjing) Co., Ltd., 2015) has gone furthest, with 0 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 | — |
https://510kreport.com/device/K943935 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943935: Gip/Medi-Globe Polypectomy Snares.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943935
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026