510(k) · Cleared
Recalled · Class II · 2026Instinct Plus 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 Aug 25, 2021 as substantially equivalent to K192697 (Cook Endoscopy, 2020) after a 30-day review. Its family tree reaches back 8 generations to 1997. It has been recalled once.
- Decided
- Aug 25, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- PKL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K963160 (1997). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 7 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- 6 generations backK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
- 5 generations backK040148 Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004 · Recalled
- 4 generations backK122660 Resolution Clip Model M00522600, M00522601, M00522602, M00522610…Boston Scientific Corporation · 2012
- 3 generations backK142973 Resolution ClipBoston Scientific Corporation · 2014
- 2 generations backK151802 Resolution ClipBoston Scientific Corporation · 2015
- 1 generation backK192697 Instinct Plus Endoscopic Clipping DeviceCook Endoscopy · 2020
- This deviceK212323 Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −7 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| −6 | K013066 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 2001 | 1 |
| −5 | K040148 | Resolution Hemostasis Clipping Device | Boston Scientific Corp | 2004 | 2 |
| −4 | K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611… | Boston Scientific Corporation | 2012 | — |
| −3 | K142973 | Resolution Clip | Boston Scientific Corporation | 2014 | — |
| −2 | K151802 | Resolution Clip | Boston Scientific Corporation | 2015 | — |
| −1 | K192697 | Instinct Plus Endoscopic Clipping Device | Cook Endoscopy | 2020 | — |
| 0 (this device) | K212323 | Instinct Plus Endoscopic Clipping Device | Wilson-Cook Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K192697 | Instinct Plus Endoscopic Clipping DeviceSummary page 4…ode Name: Hemostatic Metal Clip For The Gi Tract Regulatory Class: Class II Device Predicate Instinct Plus Endoscopic Clipping Device (K192697) Device: Description of the The Instinct Plus Endoscopic Clipping Device is a sterile, single Device:… | 2020 |
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 3, 2026 | Class II | Z-1812-2026 | Process control | Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 11 ancestors have a recall of any class.
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. 2021, this device’s year, is highlighted.
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?
This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking, 2. Hemostasis for * Mucosal/submucosal defects less than 3 cm, * Bleeding ulcers, * Arteries less than 2 mm, * Polyps less than 1.5 cm in diameter, * Diverticula in the colon, and * Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection, 3. Anchoring to affix jejunal feeding tubes to the wall of the…
Read the full statement (124 words)
This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of:
1. Endoscopic marking,
2. Hemostasis for
* Mucosal/submucosal defects less than 3 cm,
* Bleeding ulcers,
* Arteries less than 2 mm,
* Polyps less than 1.5 cm in diameter,
* Diverticula in the colon, and
* Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection,
3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel,
4. As a supplementary method for closure of GI tract luminal perforations less than 20 mm that can be treated conservatively,
5. Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212323 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212323: Instinct Plus Endoscopic Clipping Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212323
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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