510(k) · Cleared
ClearedSOLID CLIP™ Single Use Clip Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medscope Biotech Co., Ltd. · FZP Clip, Implantable
Cleared on Jul 18, 2024 as substantially equivalent to K143644 (Covidien, 2015) after a 787-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Jul 18, 2024
- Review
- 787 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K883018 (1988). 6 ancestors in all, the oldest K853650 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK883018 Auto Suture Disp. Endoscopic Surg. Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1988
- 2 generations backK061288 Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
- 1 generation backK143644 Premium Surgiclip¿; Endo Clip¿; AcuClip¿Covidien · 2015
- This deviceK221495 SOLID CLIP™ Single Use Clip ApplierMedscope Biotech Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883018 | Auto Suture Disp. Endoscopic Surg. Clip Applier | United States Surgical, A Division of Tyco Healthc | 1988 | — |
| −2 | K061288 | Auto Suture Endo Clip Iii 5 MM Clip Applier | United States Surgical, A Division of Tyco Healthc | 2006 | — |
| −1 | K143644 | Premium Surgiclip¿; Endo Clip¿; AcuClip¿ | Covidien | 2015 | — |
| 0 (this device) | K221495 | SOLID CLIP™ Single Use Clip Applier | Medscope Biotech Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 2014 | 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 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 |
|---|---|---|---|
| * | K143644 | Premium Surgiclip¿; Endo Clip¿; AcuClip¿Summary page 4…General and Plastic Surgery Product Code FZP 3. PREDICATE AND REFERENCE DEVICES Predicate Device Endo ClipTM II Clip Applier, K143644 Company Name Covidien Reference Device ENDO CLIPTM III 5mm Clip Applier, K121194 Company Name… | 2015 |
| † | K121194 | Endo Clip Iii 5MM Clip Applier | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 SOLID CLIP Single Use Clip Applier is intended for patients undergoing laparoscopic surgical procedures and can achieve dissection and ligation of blood vessels and other tubular structures for radiographic marking.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221495: SOLID CLIP™ Single Use Clip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221495
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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