510(k) · Cleared
Recalled · 2011Wilson-Cook Endoscopic Clipping Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Feb 20, 2003 as substantially equivalent to K990687 (Olympus Optical, Co., 1999) after a 90-day review. Its family tree reaches back 2 generations to 1997. 4 later devices descend from it. It has been recalled once.
- Decided
- Feb 20, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- PKL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963160 (1997). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 1 generation backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- This deviceK023903 Wilson-Cook Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK121505 Disposable Hemostasis ChipWilson-Cook Medical Inc./Cook Endoscopy · 2012
- Descendant · 2 generations on · 2 of its ownK132809 Instinct Endoscopic HemoclipWilson-Cook Medical, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK192697 Instinct Plus Endoscopic Clipping DeviceCook Endoscopy · 2020
- Descendant · 4 generations on · 0 of its ownK212323 Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 2021 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K121505Disposable Hemostasis ChipWilson-Cook Medical Inc./Cook Endoscopy · 2012 · cites it directly3descendants
- K132809Instinct Endoscopic HemoclipWilson-Cook Medical, Inc. · 2013 · 2 generations on2descendants
- K192697Instinct Plus Endoscopic Clipping DeviceCook Endoscopy · 2020 · 3 generations on1descendant
- K212323Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −1 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| 0 (this device) | K023903 | Wilson-Cook Endoscopic Clipping Device | Wilson-Cook Medical, Inc. | 2003 | — |
| +1 | K121505 | Disposable Hemostasis Chip | Wilson-Cook Medical Inc./Cook Endoscopy | 2012 | — |
| +2 | K132809 | Instinct Endoscopic Hemoclip | Wilson-Cook Medical, Inc. | 2013 | — |
| +3 | K192697 | Instinct Plus Endoscopic Clipping Device | Cook Endoscopy | 2020 | — |
| +4 | K212323 | Instinct Plus Endoscopic Clipping Device | Wilson-Cook Medical, Inc. | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 PKL? 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 PKL device
- #1 K202333 Lockado Repositionable Hemostasis Clipscore 17.5 · 7 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 |
|---|---|---|---|
| * | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsSummary page 1…ended for the repair of Gl tract lumenal perforations. Predicate Device: PREDICATE MANUFACTURER DOCUMENT DEVICE CONTROL NUMBER Olympus Endoscopic Olympus America, inc K990687 Clipping Device Substantial Equivalence: The Wilson-Cook Endoscopic Clipping Device is substantially equivalent to the referenc… | 1999 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121505 | Disposable Hemostasis Chip | 2012 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 7, 2011 | Not classified | Z-2691-2011 | Device Design | The disposable clip may not deploy after being positioned inside the patient. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K121505 (Wilson-Cook Medical Inc./Cook Endoscopy, 2012) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K990687.
How does its category compare?
All PKL devicesPKL Hemostatic Metal Clip For The Gi Tract: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PKL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PKL
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PKL
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PKL
1,170in 2025
MAUDE reports naming product code PKL, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 3 | 102 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 3 | 143 | 0 | 34 |
| 2016 | 1 | — | 0 | 128 |
| 2017 | 2 | — | 0 | 398 |
| 2018 | 5 | 116 | 0 | 393 |
| 2019 | 4 | 231 | 1 | 699 |
| 2020 | 6 | 164 | 0 | 504 |
| 2021 | 2 | — | 0 | 668 |
| 2022 | 9 | 259 | 0 | 522 |
| 2023 | 2 | — | 0 | 863 |
| 2024 | 8 | 181 | 0 | 1,216 |
| 2025 | 6 | 162 | 0 | 1,170 |
| 2026 | 7 | 231 | 0 | — |
What is it indicated for?
Used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/ submucosal defects less than 3 cm in the upper Gi tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the Gi tract. This device is not intended for the repair of Gl tract lumenal perforations.
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/K023903 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023903: Wilson-Cook Endoscopic Clipping Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023903
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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