510(k) · Cleared
Recalled · Class II · 2026X-Tack Endoscopic HeliX Tacking System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apollo Endosurgery, Inc. · PKL Hemostatic Metal Clip For The Gi Tract
Cleared on Dec 15, 2020 as substantially equivalent to K151802 (Boston Scientific Corporation, 2015) after a 167-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 15, 2020
- Review
- 167 days
- Class
- Class II
- Product code
- PKL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 7 generations to K963160 (1997). 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 deviceK201808 X-Tack Endoscopic HeliX Tacking SystemApollo Endosurgery, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK251229 EndoFix™Tissue Fixation SystemSoftac Medical Technologies · 2025
Most influential descendants
Showing 1 of 1 · See all- K251229EndoFix™Tissue Fixation SystemSoftac Medical Technologies · 2025 · 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) | K201808 | X-Tack Endoscopic HeliX Tacking System | Apollo Endosurgery, Inc. | 2020 | — |
| +1 | K251229 | EndoFix™Tissue Fixation System | Softac Medical Technologies | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K151802 | Resolution ClipSummary page 4…vice Product Code: PKL, OCW Classification: Class II (21 CFR 876.4400) Classification Name Hemorrhoidal Ligator Predicate Devices: K151802 – Resolution™ 360 Clip Device Description X-Tack™ Endoscopic HeliX Tacking System The X-Tack™… | 2015 |
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 |
|---|---|---|---|
| K251229 | EndoFix™Tissue Fixation System | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2026 | Class II | Z-2961-2026 | Under Investigation by firm | Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. |
| Jul 14, 2026 | Class II | Z-2962-2026 | Under Investigation by firm | Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. |
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.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K251229 (Softac Medical Technologies, 2025) 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?
The X-Tack™ Endoscopic HeliX Tacking System is intended for approximation of soft tissue in minimally invasive gastroenterology procedures (e.g. closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks). X-Tack is not intended for hemostasis of acute bleeding ulcers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201808: X-Tack Endoscopic HeliX Tacking System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201808
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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