510(k) · Cleared
ClearedSmith & Nephew Suturelok, Model 7207321
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · OCW Endoscopic Tissue Approximation Device
Cleared on Mar 30, 2000 as substantially equivalent to K991500 (Smith & Nephew Endoscopy, Inc., 1999) after a 27-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Mar 30, 2000
- Review
- 27 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991500 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991500 Smith & Nephew Suture LokSmith & Nephew Endoscopy, Inc. · 1999
- This deviceK000717 Smith & Nephew Suturelok, Model 7207321Smith & Nephew, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991500 | Smith & Nephew Suture Lok | Smith & Nephew Endoscopy, Inc. | 1999 | — |
| 0 (this device) | K000717 | Smith & Nephew Suturelok, Model 7207321 | Smith & Nephew, Inc. | 2000 | — |
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? (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 |
|---|---|---|---|
| * | K991500 | Smith & Nephew Suture LokSummary page 4…phew SutureLok is substantially equivalent in design, materials, function and jutended use to the following devices in commercial distribution: Smith & Nephew SutureLok-K991500 E. Description of Device The Smith & Nephew SutureLok comprises three main components: ¢ _ The suturc Lok implant (ring and pin)… | 1999 |
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?
- Its one ancestor has no recall.
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 SutureLok 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/K000717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000717: Smith & Nephew Suturelok, Model 7207321.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000717
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026