510(k) · Cleared
Recalled · Class II · 2015Reprocessed Closure System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilmed, Inc. · NLM Laparoscope, General & Plastic Surgery, Reprocessed
Cleared on Jan 22, 2014 as substantially equivalent to K980123 (Louisville Laboratories, Inc., 1998) after a 76-day review. Its family tree reaches back 1 generation to 1998. It has been recalled once.
- Decided
- Jan 22, 2014
- Review
- 76 days
- Class
- Class II
- Product code
- NLM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980123 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK980123 Carter-Thomason Needle-Point Suture Passer Instrument SetLouisville Laboratories, Inc. · 1998 · Recalled
- This deviceK133414 Reprocessed Closure SystemSterilmed, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980123 | Carter-Thomason Needle-Point Suture Passer Instrument Set | Louisville Laboratories, Inc. | 1998 | 1 |
| 0 (this device) | K133414 | Reprocessed Closure System | Sterilmed, Inc. | 2014 | — |
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 NLM? 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 NLM device
- #1 K201511 Reprocessed Endoscopic Trocars and Sleevesscore -1.9 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K980123 | Carter-Thomason Needle-Point Suture Passer Instrument SetSummary page 1…NLM Predicate The reprocessed closure systems are substantially equivalent to the Cooper Surgical Carter-Thomnason Devices: CloseSure System®o (K980123). Device The closure system is a set of three components; consisting 6f one suture passer, one 5mm guide and one Descr… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 20, 2015 | Class II | Z-1630-2015 | Component design/selection | The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad printing flaking off around the entry holes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 5 other devices also cite its predicate K980123.
How does its category compare?
All NLM devicesNLM Laparoscope, General & Plastic Surgery, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NLM
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · NLM
284in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NLM
6so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NLM
10in 2025
MAUDE reports naming product code NLM, 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 | 4 | 284 | 0 | 2 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 1 | 11 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 1 | — | 0 | 82 |
| 2013 | 1 | — | 0 | 102 |
| 2014 | 1 | — | 0 | 84 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 2 | — | 1 | 39 |
| 2017 | 2 | — | 0 | 15 |
| 2018 | 0 | — | 1 | 9 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 6 | — |
What is it indicated for?
The reprocessed closure systems are intended to pass sutures through soft tissue during endoscopic/laparoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133414: Reprocessed Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133414
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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