510(k) · Cleared
ClearedAutosuture Endo Clip Iii 5 MM Clip Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · FZP Clip, Implantable
Cleared on Nov 21, 2007 as substantially equivalent to K061288 (United States Surgical, A Division of Tyco Healthc, 2006) after a 184-day review. Its family tree reaches back 2 generations to 1988. 5 later devices descend from it.
- Decided
- Nov 21, 2007
- Review
- 184 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K883018 (1988). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK883018 Auto Suture Disp. Endoscopic Surg. Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 1988
- 1 generation backK061288 Auto Suture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2006
- This deviceK071406 Autosuture Endo Clip Iii 5 MM Clip ApplierUnited States Surgical, A Division of Tyco Healthc · 2007
- Descendant · cites it directly · 3 of its ownK121194 Endo Clip Iii 5MM Clip ApplierCovidien · 2012
- Descendant · 2 generations on · 2 of its ownK202994 InnoClip Disposable Clip Applier, InnoClip Clip ApplierTaiwan Surgical Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK253781 InnoClip Clip ApplierTaiwan Surgical Corporation · 2025
- Descendant · 3 generations on · 0 of its ownK253903 InnoClip Disposable Clip ApplierTaiwan Surgical Corporation · 2025
- Descendant · cites it directly · 0 of its ownK100242 Auto Suture Endo Clip III5MM Clip AdapterSurgical Devices, A Division of Tyco Healthcare · 2010
Most influential descendants
Showing 5 of 5 · See all- K121194Endo Clip Iii 5MM Clip ApplierCovidien · 2012 · cites it directly3descendants
- K202994InnoClip Disposable Clip Applier, InnoClip Clip ApplierTaiwan Surgical Corporation · 2022 · 2 generations on2descendants
- K253781InnoClip Clip ApplierTaiwan Surgical Corporation · 2025 · 3 generations on0descendants
- K253903InnoClip Disposable Clip ApplierTaiwan Surgical Corporation · 2025 · 3 generations on0descendants
- K100242Auto Suture Endo Clip III5MM Clip AdapterSurgical Devices, A Division of Tyco Healthcare · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883018 | Auto Suture Disp. Endoscopic Surg. Clip Applier | United States Surgical, A Division of Tyco Healthc | 1988 | — |
| −1 | K061288 | Auto Suture Endo Clip Iii 5 MM Clip Applier | United States Surgical, A Division of Tyco Healthc | 2006 | — |
| 0 (this device) | K071406 | Autosuture Endo Clip Iii 5 MM Clip Applier | United States Surgical, A Division of Tyco Healthc | 2007 | — |
| +1 | K121194 | Endo Clip Iii 5MM Clip Applier | Covidien | 2012 | — |
| +2 | K202994 | InnoClip Disposable Clip Applier, InnoClip Clip Applier | Taiwan Surgical Corporation | 2022 | — |
| +3 | K253781 | InnoClip Clip Applier | Taiwan Surgical Corporation | 2025 | — |
| +3 | K253903 | InnoClip Disposable Clip Applier | Taiwan Surgical Corporation | 2025 | — |
| +1 | K100242 | Auto Suture Endo Clip III5MM Clip Adapter | Surgical Devices, A Division of Tyco Healthcare | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K061288 | Auto Suture Endo Clip Iii 5 MM Clip ApplierSummary page 1…Implantable Clip CLASSIFICATION NAME: Implantable Clip PREDICATE DEVICE(S): Autosuture TM ENDO CLIP T M III 5mm Clip Applier (K061288) DEVICE DESCRIPTION: The AutosutureTM ENDO CLIPTM III 5mm Clip Applier contains… | 2006 |
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?
- The line of descent spans 19 years and passes through 1 company; a new generation was cleared every 18.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K121194 (Covidien, 2012) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K061288.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Auto SutureTM Endo Clip IIITM 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic markings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071406 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071406: Autosuture Endo Clip Iii 5 MM Clip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071406
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