510(k) · Cleared
Recalled · Class II · 2021NeuGuide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pop Medical Solutions · PBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Cleared on Jul 6, 2016 as substantially equivalent to K120831 (Neomedic International S.L., 2012) after a 128-day review. Its family tree reaches back 2 generations to 2004. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 6, 2016
- Review
- 128 days
- Class
- Class II
- Product code
- PBQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042603 (2004). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK042603 Gynecare Prolene Fastener SystemETHICON, Inc. · 2004
- 1 generation backK120831 AnchorsureNeomedic International S.L. · 2012
- This deviceK160569 NeuGuidePop Medical Solutions · 2016
- Descendant · cites it directly · 2 of its ownK213783 ApyxEscala Medical · 2022
- Descendant · 2 generations on · 1 of its ownK230730 ApyxEscala Medical · 2023
- Descendant · 3 generations on · 0 of its ownK260380 MenditEscala Medical, Ltd. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042603 | Gynecare Prolene Fastener System | ETHICON, Inc. | 2004 | — |
| −1 | K120831 | Anchorsure | Neomedic International S.L. | 2012 | — |
| 0 (this device) | K160569 | NeuGuide | Pop Medical Solutions | 2016 | — |
| +1 | K213783 | Apyx | Escala Medical | 2022 | — |
| +2 | K230730 | Apyx | Escala Medical | 2023 | — |
| +3 | K260380 | Mendit | Escala Medical, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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 PBQ? 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 PBQ device
- #1 K260380 Menditscore 12.1 · 5 generations · 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 |
|---|---|---|---|
| * | K120831 | AnchorsureSummary page 4…Product Code: PBQ - Fixation, non-absorbable or absorbable, for pelvic use Regulatory class: II 3. Predicate device Predicate device: K120831 Neomedic Anchorsure 4. Device description The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvi… | 2012 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213783 | Apyx | 2022 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 13, 2021 | Class II | Z-0556-2022 | Process design | Certain lots may not have been packaged wth the Channel Tube Limiter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K213783 (Escala Medical, 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K120831.
How does its category compare?
All PBQ devicesPBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PBQ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PBQ
Too few PBQ 510(k)s in any year since 2007 to give a median.
Recalls per year · PBQ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PBQ
5in 2025
MAUDE reports naming product code PBQ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
NeuGuide is indicated for attaching sutures to ligaments of the pelvic floor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160569 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160569: NeuGuide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160569
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)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026