510(k) · Cleared
ClearedSmith & Nephew Suture Lok
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Endoscopy, Inc. · OCW Endoscopic Tissue Approximation Device
Cleared on Jul 14, 1999 after a 76-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jul 14, 1999
- Review
- 76 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK991500 Smith & Nephew Suture LokSmith & Nephew Endoscopy, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK000717 Smith & Nephew Suturelok, Model 7207321Smith & Nephew, Inc. · 2000
Most influential descendants
Showing 1 of 1 · See all- K000717Smith & Nephew Suturelok, Model 7207321Smith & Nephew, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991500 | Smith & Nephew Suture Lok | Smith & Nephew Endoscopy, Inc. | 1999 | — |
| +1 | K000717 | Smith & Nephew Suturelok, Model 7207321 | Smith & Nephew, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 OCW? 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 OCW device
- #1 K252400 Endomina EZFuse systemscore 12.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | Suture Collet Named without a submission number | |
| * | — | Suture Lock Named without a submission number | |
| * | — | braided silk, nylon or polyester 0, 2-0, and 3-0 suture Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K000717 | Smith & Nephew Suturelok, Model 7207321 | 2000 | 0 |
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?
- Of its descendants, K000717 (Smith & Nephew, Inc., 2000) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, 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 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The Smith & Nephew Suture Lok is indicated for use in open and endoscopic procedures, including thoracoscopic surgery, laparoscopic procedures and general surgery. The device is not indicated for use in contraception tubal ligation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991500: Smith & Nephew Suture Lok.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991500
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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