510(k) · Cleared
Recalled · Class II · 2015Disposable Endoscopic Retrieval Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Endoscopy Group, Inc. · FGO Dislodger, Stone, Flexible
Cleared on Oct 4, 1996 after an 87-day review. The FDA summary names no predicate by number. It has been recalled 2 times.
- Decided
- Oct 4, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- FGO
- Recalls
- 2
- Predicates
- 0
The FDA summary names no predicate by number.
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 FGO? 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?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 10, 2015 | Class II | Z-1453-2015 | Under Investigation by firm | A wire component on the distal grasping assembly of the device became detached.. |
| Nov 14, 2011 | Class II | Z-0006-2013 | Device Design | When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All FGO devicesFGO Dislodger, Stone, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGO
FDA has decided no FGO device since 2007.
Median 510(k) review, days · FGO
Too few FGO 510(k)s in any year since 2007 to give a median.
Recalls per year · FGO
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGO
10in 2025
MAUDE reports naming product code FGO, 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 | 2 |
| 2008 | 0 | — | 0 | 23 |
| 2009 | 0 | — | 0 | 32 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 1 | 15 |
| 2012 | 0 | — | 0 | 13 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 0 | — | 0 | 17 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 14 |
| 2024 | 0 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K962676 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962676: Disposable Endoscopic Retrieval Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962676
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026