510(k) · Cleared
ClearedCLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taiwan Surgical Corporation · FZP Clip, Implantable
Cleared on Nov 6, 2015 as substantially equivalent to K013695 (Microline Pentax, Inc., 2002) after a 276-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Nov 6, 2015
- Review
- 276 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013695 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK013695 Microline Inc. Reusable Laparoscopic Clip Applier with Implantable…Microline Pentax, Inc. · 2002
- This deviceK150259 CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip…Taiwan Surgical Corporation · 2015
- Descendant · cites it directly · 0 of its ownK253781 InnoClip Clip ApplierTaiwan Surgical Corporation · 2025
- Descendant · cites it directly · 0 of its ownK253903 InnoClip Disposable Clip ApplierTaiwan Surgical Corporation · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013695 | Microline Inc. Reusable Laparoscopic Clip Applier with Implantable Titanium… | Microline Pentax, Inc. | 2002 | — |
| 0 (this device) | K150259 | CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L | Taiwan Surgical Corporation | 2015 | — |
| +1 | K253781 | InnoClip Clip Applier | Taiwan Surgical Corporation | 2025 | — |
| +1 | K253903 | InnoClip Disposable Clip Applier | Taiwan Surgical Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 FZP? 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 FZP device
- #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 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 |
|---|---|---|---|
| * | K013695 | Microline Inc. Reusable Laparoscopic Clip Applier with Implantable Titanium Clips, Model…Summary page 5…K150259, Page 2 of 5 III. PREDICATE DEVICE Predicate Device 1: MICROLINE PENTAX, INC., K013695 Table 2. Predicate Device Identification P… | 2002 |
What descends from it? (2)
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, K253781 (Taiwan Surgical Corporation, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · FZP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FZP
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FZP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FZP
1,902in 2025
MAUDE reports naming product code FZP, 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 | 6 | 31 | 1 | 1,877 |
| 2008 | 4 | 23 | 6 | 981 |
| 2009 | 3 | 22 | 0 | 2,160 |
| 2010 | 6 | 47 | 1 | 2,367 |
| 2011 | 3 | 124 | 0 | 1,678 |
| 2012 | 2 | — | 1 | 1,677 |
| 2013 | 3 | 47 | 0 | 2,381 |
| 2014 | 3 | 29 | 1 | 2,320 |
| 2015 | 8 | 182 | 0 | 2,871 |
| 2016 | 5 | 72 | 2 | 1,840 |
| 2017 | 4 | 29 | 1 | 2,594 |
| 2018 | 4 | 143 | 0 | 2,718 |
| 2019 | 1 | — | 3 | 2,903 |
| 2020 | 2 | — | 1 | 1,760 |
| 2021 | 0 | — | 0 | 1,759 |
| 2022 | 3 | 227 | 0 | 1,575 |
| 2023 | 3 | 65 | 0 | 1,918 |
| 2024 | 2 | — | 0 | 2,067 |
| 2025 | 5 | 90 | 0 | 1,902 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The use of the product is indicated in endoscopic procedures, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula for the purpose of ligating vessels and tubular structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150259: CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150259
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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