510(k) · Cleared
ClearedInstinct Plus Endoscopic Clipping Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Endoscopy · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Mar 5, 2020 as substantially equivalent to K151802 (Boston Scientific Corporation, 2015) and 1 other predicate after a 161-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.
- Decided
- Mar 5, 2020
- Review
- 161 days
- Class
- Class II
- Product code
- PKL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K963160 (1997). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 6 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- 5 generations backK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
- 4 generations backK040148 Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004 · Recalled
- 3 generations backK122660 Resolution Clip Model M00522600, M00522601, M00522602, M00522610…Boston Scientific Corporation · 2012
- 2 generations backK142973 Resolution ClipBoston Scientific Corporation · 2014
- 1 generation backK151802 Resolution ClipBoston Scientific Corporation · 2015
- This deviceK192697 Instinct Plus Endoscopic Clipping DeviceCook Endoscopy · 2020
- Descendant · cites it directly · 0 of its ownK212323 Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 2021 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K212323Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −6 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| −5 | K013066 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 2001 | 1 |
| −4 | K040148 | Resolution Hemostasis Clipping Device | Boston Scientific Corp | 2004 | 2 |
| −3 | K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611… | Boston Scientific Corporation | 2012 | — |
| −2 | K142973 | Resolution Clip | Boston Scientific Corporation | 2014 | — |
| −1 | K151802 | Resolution Clip | Boston Scientific Corporation | 2015 | — |
| 0 (this device) | K192697 | Instinct Plus Endoscopic Clipping Device | Cook Endoscopy | 2020 | — |
| +1 | K212323 | Instinct Plus Endoscopic Clipping Device | Wilson-Cook Medical, Inc. | 2021 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K151802 | Resolution ClipSummary page 4…: PKL Product Code Name: Hemostatic Metal Clip for the Gi Tract Regulatory Class: II Predicate Devices: • K151802 Resolution™ 360 Clip (primary) • K132809 Instinct Endoscopic Hemoclip (secondary) Device Description: The Instinct Plus Endos… | 2015 |
| * | K132809 | Instinct Endoscopic HemoclipSummary page 4…e: Hemostatic Metal Clip for the Gi Tract Regulatory Class: II Predicate Devices: • K151802 Resolution™ 360 Clip (primary) • K132809 Instinct Endoscopic Hemoclip (secondary) Device Description: The Instinct Plus Endoscopic Clipping Device is a sterile, single us… | 2013 |
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 |
|---|---|---|---|
| K212323 | Instinct Plus Endoscopic Clipping Device | 2021 | 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?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K212323 (Wilson-Cook Medical, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K151802.
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. 2020, 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 (123 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 20mm 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/K192697 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192697: 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/K192697
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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