PMA · Approved
Recalled · 2005Enteryx Procedure Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · LNM Agent, Bulking, Injectable For Gastro-Urology Use
Approved on Apr 22, 2003 through premarket approval, which rests on the device’s own clinical evidence after a 435-day review. It has been recalled once.
- Decided
- Apr 22, 2003
- Review
- 435 days
- Class
- Class III
- Product code
- LNM
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P020006 has 4 supplements since 2003: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LNM? 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
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 |
|---|---|---|---|---|
| Sep 23, 2005 | Not classified | Z-0040-06 | Other | Incorrect implantation may cause serious health complications |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LNM devicesLNM Agent, Bulking, Injectable For Gastro-Urology Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNM
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNM
Too few LNM 510(k)s in any year since 2007 to give a median.
Recalls per year · LNM
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LNM
59in 2025
MAUDE reports naming product code LNM, 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 | 19 | — | 0 | 45 |
| 2008 | 26 | — | 0 | 25 |
| 2009 | 18 | — | 0 | 25 |
| 2010 | 9 | — | 0 | 38 |
| 2011 | 10 | — | 0 | 55 |
| 2012 | 12 | — | 0 | 60 |
| 2013 | 12 | — | 0 | 62 |
| 2014 | 16 | — | 0 | 52 |
| 2015 | 7 | — | 0 | 59 |
| 2016 | 3 | — | 0 | 72 |
| 2017 | 7 | — | 0 | 86 |
| 2018 | 7 | — | 0 | 36 |
| 2019 | 10 | — | 0 | 8 |
| 2020 | 23 | — | 1 | 7 |
| 2021 | 5 | — | 0 | 11 |
| 2022 | 13 | — | 0 | 18 |
| 2023 | 14 | — | 0 | 16 |
| 2024 | 8 | — | 0 | 65 |
| 2025 | 7 | — | 0 | 59 |
| 2026 | 7 | — | 0 | — |
https://510kreport.com/device/P020006 · printed Nov 6, 2026
Cite this page
510(k) Report. “P020006: Enteryx Procedure Kit.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P020006
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026