510(k) · Cleared
ClearedSureline Laparoscopic Clip Applier with Implantable Titanium Clips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Design Standards Corp. · FZP Clip, Implantable
Cleared on May 10, 2004 as substantially equivalent to K981645 (Vitalitec Int'L., Inc., 1998) and 3 other predicates after a 63-day review. Its family tree reaches back 3 generations to 1977.
- Decided
- May 10, 2004
- Review
- 63 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K771021 (1977). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK771021 Auto-ClipAxiom Medical, Inc. · 1977
- 2 generations backK972745 Titanium Hemostatic ClipEisner USA, Inc. · 1997
- 1 generation backK981645 Titanium Hemostatic ClipVitalitec Int'L., Inc. · 1998
- This deviceK040602 Sureline Laparoscopic Clip Applier with Implantable Titanium ClipsDesign Standards Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K771021 | Auto-Clip | Axiom Medical, Inc. | 1977 | — |
| −2 | K972745 | Titanium Hemostatic Clip | Eisner USA, Inc. | 1997 | — |
| −1 | K981645 | Titanium Hemostatic Clip | Vitalitec Int'L., Inc. | 1998 | — |
| 0 (this device) | K040602 | Sureline Laparoscopic Clip Applier with Implantable Titanium Clips | Design Standards Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1989 | 1 | 0 |
| 1996 | 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? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981645 | Titanium Hemostatic ClipSummary page 1…878.4300, Class II (3) Predicates: Vitalitec International (k981645) Microsurge Sureline (964109)… | 1998 |
| * | K964109 | Microsurge Laparoscopic Permaclip Cartridge with Implantable ClipSummary page 1…rnational (k981645) Microsurge Sureline (964109) United States Surgical Corporation (K88308… | 1996 |
| Kept off the family tree | K883081 | FDA’s K883081 is Radkor, XG-515 Our reading of the summary gave K883081, FDA’s number for Radkor, XG-515 (Radkor, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “United States Surgical Corporation”. Kept off the family tree. Summary page 1…(964109) United States Surgical Corporation (K883081, K890941) Ethicon Endosurgery (K920387) Pil… | 1988 |
| * | K890941 | Modified Suture Disp. Endoscopic Surgical Clip AppSummary page 1…(964109) United States Surgical Corporation (K883081, K890941) Ethicon Endosurgery (K920387) Pilling Weck… | 1989 |
| Kept off the family tree | K920387 | FDA’s K920387 is Circlexo.3T X-Ray Tube Assembly Our reading of the summary gave K920387, FDA’s number for Circlexo.3T X-Ray Tube Assembly (Shimadzu Medical Systems). Its FDA name has none of the distinctive words the summary uses for the device it names, “Ethicon Endosurgery”. Kept off the family tree. Summary page 1…United States Surgical Corporation (K883081, K890941) Ethicon Endosurgery (K920387) Pilling Weck (K851251, K905837)) (4) Description of Device: The Sureline… | 1992 |
| * | K851251 | Auto/Manual Titanium Hemoclip Ligating Clip 527200Summary page 1…(K883081, K890941) Ethicon Endosurgery (K920387) Pilling Weck (K851251, K905837)) (4) Description of Device: The SurelineTM Laparoscopic Clip Applier with implantable titanium clips… | 1985 |
| Kept off the family tree | K905837 | Pilling Weck Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…(K883081, K890941) Ethicon Endosurgery (K920387) Pilling Weck (K851251, K905837)) (4) Description of Device: The SurelineTM Laparoscopic Clip Applier with implantable titanium clips is… |
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 27 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 2 other devices also cite its predicate K981645.
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 | — |
What is it indicated for?
The Sureline Laparoscopic Clip Applier with Implantable Titanium clips is intended for use in a variety of laparoscopic procedures to occlude tubular structures and blood vessels. The tissue being ligated should be consistent with the size of the clip.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040602: Sureline Laparoscopic Clip Applier with Implantable Titanium Clips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040602
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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