510(k) · Cleared
ClearedAnchorsure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neomedic International S.L. · PBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Cleared on Oct 12, 2012 as substantially equivalent to K042603 (ETHICON, Inc., 2004) after a 207-day review. Its family tree reaches back 1 generation to 2004. 5 later devices descend from it.
- Decided
- Oct 12, 2012
- Review
- 207 days
- Class
- Class II
- Product code
- PBQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042603 (2004). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK042603 Gynecare Prolene Fastener SystemETHICON, Inc. · 2004
- This deviceK120831 AnchorsureNeomedic International S.L. · 2012
- Descendant · cites it directly · 3 of its ownK160569 NeuGuidePop Medical Solutions · 2016 · Recalled
- Descendant · 2 generations on · 2 of its ownK213783 ApyxEscala Medical · 2022
- Descendant · 3 generations on · 1 of its ownK230730 ApyxEscala Medical · 2023
- Descendant · 4 generations on · 0 of its ownK260380 MenditEscala Medical, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK220420 Saffron Fixation SystemColoplast A/S · 2022
Most influential descendants
Showing 5 of 5 · See all- K160569NeuGuidePop Medical Solutions · 2016 · cites it directly3descendants
- K213783ApyxEscala Medical · 2022 · 2 generations on2descendants
- K230730ApyxEscala Medical · 2023 · 3 generations on1descendant
- K260380MenditEscala Medical, Ltd. · 2026 · 4 generations on0descendants
- K220420Saffron Fixation SystemColoplast A/S · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042603 | Gynecare Prolene Fastener System | ETHICON, Inc. | 2004 | — |
| 0 (this device) | K120831 | Anchorsure | Neomedic International S.L. | 2012 | — |
| +1 | K160569 | NeuGuide | Pop Medical Solutions | 2016 | 1 |
| +2 | K213783 | Apyx | Escala Medical | 2022 | — |
| +3 | K230730 | Apyx | Escala Medical | 2023 | — |
| +4 | K260380 | Mendit | Escala Medical, Ltd. | 2026 | — |
| +1 | K220420 | Saffron Fixation System | Coloplast A/S | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K042603 | Gynecare Prolene Fastener SystemSummary page 1…Obstetric-gynecologic specialized manual instrument PRODUCT CODE: PBQ PREDICATE DEVICES: GYNECARE PROLENE FASTENER SYSTEM (K042603) Device Description: Anchorsure is a suture kit that consists of monofilament polypropylene suture, an anchor, an anchoring han… | 2004 |
| † | K102815 | Surelift Prolapse System | 2011 |
What descends from it? (5)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K160569 (Pop Medical Solutions, 2016) has gone furthest, with 3 descendants of its own.
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. 2012, 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?
Anchorsure is indicated for attaching suture to ligaments of the pelvic floor
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120831: Anchorsure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120831
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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