510(k) · Cleared
Recalled · Class II · 2014Hemoclip Surgical Occluding Clip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edward Weck, Inc. · FZP Clip, Implantable
Cleared on Jan 28, 1980 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled once.
- Decided
- Jan 28, 1980
- Review
- 14 days
- Class
- Class II
- Product code
- FZP
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK800079 Hemoclip Surgical Occluding ClipEdward Weck, Inc. · 1980
- Descendant · cites it directly · 4 of its ownK972745 Titanium Hemostatic ClipEisner USA, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK981645 Titanium Hemostatic ClipVitalitec Int'L., Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK242541 Gem ZipclipSynovis Micro Companies Alliance A Subsidiary of Baxter Int · 2025
- Descendant · 2 generations on · 0 of its ownK192711 Dannik Titanium Ligation ClipDannik · 2019
- Descendant · 2 generations on · 0 of its ownK040602 Sureline Laparoscopic Clip Applier with Implantable Titanium ClipsDesign Standards Corp. · 2004
Most influential descendants
Showing 5 of 5 · See all- K972745Titanium Hemostatic ClipEisner USA, Inc. · 1997 · cites it directly4descendants
- K981645Titanium Hemostatic ClipVitalitec Int'L., Inc. · 1998 · cites it directly3descendants
- K242541Gem ZipclipSynovis Micro Companies Alliance A Subsidiary of Baxter Int · 2025 · 2 generations on0descendants
- K192711Dannik Titanium Ligation ClipDannik · 2019 · 2 generations on0descendants
- K040602Sureline Laparoscopic Clip Applier with Implantable Titanium ClipsDesign Standards Corp. · 2004 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K800079 | Hemoclip Surgical Occluding Clip | Edward Weck, Inc. | 1980 | — |
| +1 | K972745 | Titanium Hemostatic Clip | Eisner USA, Inc. | 1997 | — |
| +1 | K981645 | Titanium Hemostatic Clip | Vitalitec Int'L., Inc. | 1998 | — |
| +2 | K242541 | Gem Zipclip | Synovis Micro Companies Alliance A Subsidiary of Baxter Int | 2025 | — |
| +2 | K192711 | Dannik Titanium Ligation Clip | Dannik | 2019 | — |
| +2 | K040602 | Sureline Laparoscopic Clip Applier with Implantable Titanium Clips | Design Standards Corp. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 3, 2014 | Class II | Z-0826-2015 | Labeling Change Control | The manufacturing dates and expiration dates were transposed on the Tyvek label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K972745 (Eisner USA, Inc., 1997) has gone furthest, with 4 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.
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 | — |
https://510kreport.com/device/K800079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K800079: Hemoclip Surgical Occluding Clip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K800079
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026